SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
Check drug filings and source records for this company-name string.
Listed by the company name as recorded in the source, without merging affiliated entities.
Page reference ba98a378be
Drug names108First applicant · distinct drug namesAcceptance records174First applicant · distinct acceptance numbersUnder-review numbers20First applicant · current under-review listCo-applicant records11Subsequent applicant only · separate count
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/11 06:42.
Drug filings
174 acceptance records as first applicant, grouped into 108 source drug names. Source data as of 2026/11/11 06:42.
Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.
Empagliflozin Tablets 2 records · Latest accepted 2026/11/04
Supplement · 1Generic · 1
Nefopam Hydrochloride Injection 1 records · Latest accepted 2026/10/28
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2650213 | Supplement | 2026/10/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Dexketoprofen Trometamol Injection 2 records · Latest accepted 2026/09/07
Generic · 2
Sacubitril Valsartan Sodium Tablets 3 records · Latest accepted 2026/07/21
Supplement · 1Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601384 | Supplement | 2026/07/21 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2501636 | Generic | 2025/05/01 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2401428 | Generic | 2024/05/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2026/07/20
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2650163 | Supplement | 2026/07/20 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Polycarbophil Calcium Tablets 1 records · Latest accepted 2026/06/30
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2650147 | Supplement | 2026/06/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 1 records · Latest accepted 2026/06/12
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601124 | Supplement | 2026/06/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 1 records · Latest accepted 2026/06/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601217 | Generic | 2026/06/01 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CDE ↗ |
Ibuprofen Injection 7 records · Latest accepted 2026/05/13
Generic · 7
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601110 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHS2601109 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHL2400067 | Generic | 2024/03/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHL2400066 | Generic | 2024/03/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHL2300136 | Generic | 2023/11/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHS2201923 | Generic | 2022/11/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHS2201922 | Generic | 2022/11/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Polidocanol Injection 2 records · Latest accepted 2026/05/13
Generic · 2
No verified English name 1 records · Latest accepted 2026/04/10
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2600424 | New drug | 2026/04/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Potassium Chloride Granules 1 records · Latest accepted 2026/03/28
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600620 | Supplement | 2026/03/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Nanjing Hai Jing Pharma Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2026/03/09
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600473 | Supplement | 2026/03/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ezetimibe Tablets 1 records · Latest accepted 2026/02/10
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600297 | Supplement | 2026/02/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Azilsartan Medoxomil Potassium Tablets 4 records · Latest accepted 2026/01/31
Generic · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600324 | Generic | 2026/01/31 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2600323 | Generic | 2026/01/31 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2503780 | Generic | 2025/10/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2503778 | Generic | 2025/10/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Multiple Electrolyte Additive For Injection 1 records · Latest accepted 2026/01/22
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600135 | Supplement | 2026/01/22 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Mecobalamin Tablets 3 records · Latest accepted 2026/01/17
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600090 | Supplement | 2026/01/17 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Hai Wang Zhong Xin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2502339 | Supplement | 2025/11/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Hai Wang Zhong Xin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2500726 | Supplement | 2025/04/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Hai Wang Zhong Xin Pharma Co., Ltd. romanized | CDE ↗ |
Perampanel Tablets 2 records · Latest accepted 2025/12/25
Generic · 2
Potassium Chloride Injection 1 records · Latest accepted 2025/08/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503088 | Generic | 2025/08/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangdong Sunho Pharmaceutical Co., Ltd. | CDE ↗ |
No verified English name 1 records · Latest accepted 2025/08/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502989 | Generic | 2025/08/15 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized | CDE ↗ |
No verified English name 3 records · Latest accepted 2025/08/12
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501611 | Supplement | 2025/08/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2402223 | Supplement | 2024/12/26 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2402222 | Supplement | 2024/12/26 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Oral Solution 2 records · Latest accepted 2025/08/12
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501599 | Supplement | 2025/08/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Wan Run Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2300599 | Supplement | 2023/03/24 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CDE ↗ |
Citicoline Sodium Injection 3 records · Latest accepted 2025/08/12
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2550286 | Supplement | 2025/08/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2350259 | Supplement | 2023/03/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2250222 | Supplement | 2022/04/19 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 4 records · Latest accepted 2025/07/11
New drug · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2500674 | New drug | 2025/07/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CXHL2500673 | New drug | 2025/07/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CXHL2500672 | New drug | 2025/07/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CXHL2500671 | New drug | 2025/07/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Nimodipine Tablets 1 records · Latest accepted 2025/07/04
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2550245 | Supplement | 2025/07/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Perampanel oral suspension 1 records · Latest accepted 2025/06/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502299 | Generic | 2025/06/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Vonoprazan Fumarate Tablets 1 records · Latest accepted 2025/06/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502271 | Generic | 2025/06/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Bumetanide Injection 2 records · Latest accepted 2025/06/24
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501239 | Supplement | 2025/06/24 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2501238 | Supplement | 2025/06/24 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diphenhydramine Hydrochloride Tablets 1 records · Latest accepted 2025/06/12
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501175 | Supplement | 2025/06/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Avatrombopag Maleate Tablets 1 records · Latest accepted 2025/06/11
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501163 | Supplement | 2025/06/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Cheng Kang Pharma Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2025/06/10
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501161 | Supplement | 2025/06/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangdong Hua Nan Pharma Group Co., Ltd. romanized | CDE ↗ |
Phenobarbital Tablets 1 records · Latest accepted 2025/05/31
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2550202 | Supplement | 2025/05/31 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Famotidine Injection 1 records · Latest accepted 2025/04/30
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501619 | Generic | 2025/04/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Minsheng Pharmaceutical Co., Ltd | CDE ↗ |
Dapoxetine Hydrochloride Tablets 1 records · Latest accepted 2025/04/14
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501422 | Generic | 2025/04/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Epalrestat Tablets 1 records · Latest accepted 2025/04/11
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500728 | Supplement | 2025/04/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Ningbo Mei Nuo Hua Tian Kang Pharma Co., Ltd. romanized | CDE ↗ |
Aminophylline Injection 2 records · Latest accepted 2025/03/15
Supplement · 2
Estazolam Tablets 2 records · Latest accepted 2025/03/15
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500531 | Supplement | 2025/03/15 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangxi Da Hai Yang Guang Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2500530 | Supplement | 2025/03/15 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangxi Da Hai Yang Guang Pharma Co., Ltd. romanized | CDE ↗ |
Dapagliflozin Tablets 2 records · Latest accepted 2025/03/10
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500994 | Generic | 2025/03/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2500993 | Generic | 2025/03/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ketorolac Tromethamine Injection 1 records · Latest accepted 2025/02/20
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500798 | Generic | 2025/02/20 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Clopidogrel Hydrogen Sulphate Tablets 1 records · Latest accepted 2025/02/05
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2500234 | Supplement | 2025/02/05 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Levocarnitine Oral Solution 1 records · Latest accepted 2024/12/06
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2404213 | Generic | 2024/12/06 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
No verified English name 6 records · Latest accepted 2024/12/06
Supplement · 6
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2402074 | Supplement | 2024/12/06 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2402073 | Supplement | 2024/12/06 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2401547 | Supplement | 2024/09/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2401546 | Supplement | 2024/09/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400626 | Supplement | 2024/05/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400625 | Supplement | 2024/05/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2024/12/05
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2402066 | Supplement | 2024/12/05 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Lactulose Oral Solution 3 records · Latest accepted 2024/12/03
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2402039 | Supplement | 2024/12/03 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2401865 | Supplement | 2024/11/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized | CDE ↗ |
| CYHB2401578 | Supplement | 2024/09/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized | CDE ↗ |
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 1 records · Latest accepted 2024/11/30
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2404119 | Generic | 2024/11/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Sevelamer Carbonate Powder for oral suspension 2 records · Latest accepted 2024/11/23
Generic · 2
Esmolol Hydrochloride Injection 1 records · Latest accepted 2024/11/09
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401849 | Supplement | 2024/11/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
Entacapone Tablets 1 records · Latest accepted 2024/10/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403452 | Generic | 2024/10/15 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diprophylline Injection 1 records · Latest accepted 2024/09/21
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401535 | Supplement | 2024/09/21 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized | CDE ↗ |
Valsartan Capsules 1 records · Latest accepted 2024/09/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402871 | Generic | 2024/09/02 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Diazepam Tablets 4 records · Latest accepted 2024/08/13
Supplement · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401253 | Supplement | 2024/08/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jilin Xian Feng Technology Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2401252 | Supplement | 2024/08/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jilin Xian Feng Technology Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400493 | Supplement | 2024/04/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jilin Xian Feng Technology Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400492 | Supplement | 2024/04/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jilin Xian Feng Technology Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Glucosamine Sulfate Capsules 1 records · Latest accepted 2024/08/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402615 | Generic | 2024/08/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Pentoxifylline Injection 1 records · Latest accepted 2024/08/09
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401223 | Supplement | 2024/08/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Piracetam Injection 2 records · Latest accepted 2024/07/31
Supplement · 2
Phloroglucinol Injection 1 records · Latest accepted 2024/07/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402195 | Generic | 2024/07/16 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ibuprofen and Phenylephrine Hydrochloride Tablets 1 records · Latest accepted 2024/07/09
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHL2400138 | Generic | 2024/07/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Tadalafil Tablets 3 records · Latest accepted 2024/06/27
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400909 | Supplement | 2024/06/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400908 | Supplement | 2024/06/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2400307 | Supplement | 2024/02/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution 1 records · Latest accepted 2024/05/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401549 | Generic | 2024/05/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhong Fu Pharma Co., Ltd. romanized | CDE ↗ |
Miconazole Nitrate Vaginal Soft Capsules 2 records · Latest accepted 2024/05/21
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400681 | Supplement | 2024/05/21 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CDE ↗ |
| CYHB2400680 | Supplement | 2024/05/21 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CDE ↗ |
Rabeprazole Sodium Enteric-coated Tablets 4 records · Latest accepted 2024/05/14
Supplement · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400651 | Supplement | 2024/05/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2400064 | Supplement | 2024/01/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2250512 | Supplement | 2022/08/16 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2250436 | Supplement | 2022/07/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Sildenafil Citrate Oral Disintegrating Tablets 1 records · Latest accepted 2024/04/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401280 | Generic | 2024/04/26 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Oseltamivir Phosphate For Oral Suspension 1 records · Latest accepted 2024/04/17
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401142 | Generic | 2024/04/17 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Aspirin Enteric-coated Tablets 1 records · Latest accepted 2024/03/19
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450201 | Supplement | 2024/03/19 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Peramivir Injection 2 records · Latest accepted 2024/03/14
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400369 | Supplement | 2024/03/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhejiang Guo Jing Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2400368 | Supplement | 2024/03/14 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Aminophylline Tablets 1 records · Latest accepted 2024/03/04
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450168 | Supplement | 2024/03/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Bisoprolol Fumarate Tablets 2 records · Latest accepted 2024/02/28
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400706 | Generic | 2024/02/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2400705 | Generic | 2024/02/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2024/02/28
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450157 | Supplement | 2024/02/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Lacosamide Injection 2 records · Latest accepted 2024/02/27
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2400306 | Supplement | 2024/02/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2301956 | Supplement | 2023/08/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
Lidocaine and Prilocaine Cream 1 records · Latest accepted 2024/02/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400440 | Generic | 2024/02/02 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Tramadol Hydrochloride SR Tablets 2 records · Latest accepted 2024/01/24
Supplement · 2
Esomeprazole Sodium for Injection 1 records · Latest accepted 2023/12/08
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2302685 | Supplement | 2023/12/08 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hainan Pu Li Pharmaceutical Co., Ltd. romanized | CDE ↗ |
No verified English name 2 records · Latest accepted 2023/11/30
Generic · 2
No verified English name 1 records · Latest accepted 2023/11/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2303229 | Generic | 2023/11/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
Ethyl Iosapentate Capsules 2 records · Latest accepted 2023/11/11
Generic · 2
Amlodipine Besylate Tablets 1 records · Latest accepted 2023/10/12
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2302267 | Supplement | 2023/10/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Beijing Han Dian Pharmaceutical Co., Ltd. romanized | CDE ↗ |
No verified English name 2 records · Latest accepted 2023/10/09
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302644 | Generic | 2023/10/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2302643 | Generic | 2023/10/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Pregabalin Oral Solution 1 records · Latest accepted 2023/09/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302592 | Generic | 2023/09/26 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 1 records · Latest accepted 2023/09/16
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2302099 | Supplement | 2023/09/16 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CDE ↗ |
Tofacitinib Citrate Tablets 2 records · Latest accepted 2023/09/16
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2302110 | Supplement | 2023/09/16 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2102135 | Supplement | 2021/11/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Memantine Hydrochloride Oral Solution 1 records · Latest accepted 2023/09/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302462 | Generic | 2023/09/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 1 records · Latest accepted 2023/09/02
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2301971 | Supplement | 2023/09/02 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CDE ↗ |
Topiroxostat Tablets 2 records · Latest accepted 2023/07/29
Generic · 2
Calcium Gluconate Injection 1 records · Latest accepted 2023/07/11
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350545 | Supplement | 2023/07/11 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Memantine Hydrochloride Tablets 1 records · Latest accepted 2023/06/27
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2301401 | Supplement | 2023/06/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized | CDE ↗ |
Sevelamer Carbonate Tablets 2 records · Latest accepted 2023/05/23
Supplement · 1Generic · 1
Pentazocine Injection 1 records · Latest accepted 2023/05/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301361 | Generic | 2023/05/22 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Naloxone Hydrochloride Injection 3 records · Latest accepted 2023/04/04
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350315 | Supplement | 2023/04/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2350314 | Supplement | 2023/04/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| CYHB2350313 | Supplement | 2023/04/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Sodium Bicarbonate Injection 2 records · Latest accepted 2023/03/17
Supplement · 2
Digoxin Tablets 1 records · Latest accepted 2023/03/10
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2300533 | Supplement | 2023/03/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | CDE ↗ |
No verified English name 2 records · Latest accepted 2022/10/18
New drug · 2
Ibuprofen Sustained Release Capsules 1 records · Latest accepted 2022/06/30
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200983 | Generic | 2022/06/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Escitalopram Oxalate Tablets 1 records · Latest accepted 2022/06/20
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200872 | Generic | 2022/06/20 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Pregabalin Capsules 2 records · Latest accepted 2022/06/14
Generic · 2
Atorvastatin Calcium Tablets 2 records · Latest accepted 2022/04/22
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2200648 | Supplement | 2022/04/22 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Min Sheng Bin Jiang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2200647 | Supplement | 2022/04/22 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Min Sheng Bin Jiang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Alogliptin Benzoate Tablets 2 records · Latest accepted 2022/03/09
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200420 | Generic | 2022/03/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| CYHS2200419 | Generic | 2022/03/09 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2022/02/10
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2200294 | Supplement | 2022/02/10 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Apixaban Tablets 1 records · Latest accepted 2022/02/07
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200263 | Generic | 2022/02/07 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
Dobutamine Hydrochloride Injection 1 records · Latest accepted 2022/01/19
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2250052 | Supplement | 2022/01/19 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Valsartan and Amlodipine Tablets（I） 1 records · Latest accepted 2021/12/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2102233 | Generic | 2021/12/22 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | CDE ↗ |
Meloxicam Capsules 1 records · Latest accepted 2021/12/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2151097 | Supplement | 2021/12/17 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Furosemide Injection 1 records · Latest accepted 2021/10/19
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150912 | Supplement | 2021/10/19 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 2 records · Latest accepted 2021/05/14
Supplement · 2
Fasudil Hydrochloride Injection 1 records · Latest accepted 2021/03/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2101036 | Supplement | 2021/03/18 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Edaravone Injection 1 records · Latest accepted 2021/03/03
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2101020 | Supplement | 2021/03/03 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Irbesartan Tablets 1 records · Latest accepted 2021/03/03
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2101002 | Supplement | 2021/03/03 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Glimepiride Tablets 2 records · Latest accepted 2021/02/09
Supplement · 2
Compound Sulfamethoxazole Tablets 1 records · Latest accepted 2021/01/01
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2050812 | Supplement | 2021/01/01 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
No verified English name 1 records · Latest accepted 2021/01/01
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2050813 | Supplement | 2021/01/01 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
Changes in the last 90 days
6 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.
This source was last successfully updated at 2026/11/10 18:31; current coverage may be incomplete.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
Marketing application approved: 1 applicationAccepted: 3 applicationsNo longer listed under review: 1 applicationSupplement delivery: 1 application
- 2026/11/07No longer listed under review
Sacubitril Valsartan Sodium Tablets
CYHB2601384
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2026/07/21
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 20
NMPA · Table row 20 ↗ View source ↗ - 2026/11/05Supplement delivery
Sacubitril Valsartan Sodium Tablets
CYHB2601384
Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06
Supplemental application; excluded from new marketing approvals.
View source · Table row 20 ↗ - 2026/11/04Accepted
Empagliflozin Tablets
CYHB2601999
Fact date: 2026/11/04 · Site observation date: 2026/11/05
View source ↗ - 2026/11/03Marketing application approved
Ketorolac Tromethamine Injection
CYHS2500798 · 国药准字H20266508
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
View source · Table row 31 ↗ - 2026/10/28Accepted
Nefopam Hydrochloride Injection
CYHB2650213
Fact date: 2026/10/28 · Site observation date: 2026/10/29
View source ↗ - 2026/09/07Accepted
Dexketoprofen Trometamol Injection
CYHS2602215
Fact date: 2026/09/07 · Site observation date: 2026/10/22
View source ↗
Under review
20 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/11 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Empagliflozin Tablets | CYHB2601999 | Supplement | 2026/11/04 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Nefopam Hydrochloride Injection | CYHB2650213 | Supplement | 2026/10/28 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Dexketoprofen Trometamol Injection | CYHS2602215 | Generic | 2026/09/07 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2650163 | Supplement | 2026/07/20 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Polycarbophil Calcium Tablets | CYHB2650147 | Supplement | 2026/06/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHS2601217 | Generic | 2026/06/01 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CDE ↗ |
| Ibuprofen Injection | CYHS2601110 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Ibuprofen Injection | CYHS2601109 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Polidocanol Injection | CYHS2601100 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Polidocanol Injection | CYHS2601099 | Generic | 2026/05/13 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Azilsartan Medoxomil Potassium Tablets | CYHS2600324 | Generic | 2026/01/31 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| Azilsartan Medoxomil Potassium Tablets | CYHS2600323 | Generic | 2026/01/31 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| Perampanel Tablets | CYHS2504405 | Generic | 2025/12/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Perampanel Tablets | CYHS2504404 | Generic | 2025/12/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Potassium Chloride Injection | CYHS2503088 | Generic | 2025/08/23 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Guangdong Sunho Pharmaceutical Co., Ltd. | CDE ↗ |
| No verified English name | CYHS2502989 | Generic | 2025/08/15 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized | CDE ↗ |
| Ambroxol Hydrochloride Oral Solution | CYHB2501599 | Supplement | 2025/08/12 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Wan Run Pharma Co., Ltd. romanized | CDE ↗ |
| Perampanel oral suspension | CYHS2502299 | Generic | 2025/06/27 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Vonoprazan Fumarate Tablets | CYHS2502271 | Generic | 2025/06/25 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | CDE ↗ |
| Famotidine Injection | CYHS2501619 | Generic | 2025/04/30 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Minsheng Pharmaceutical Co., Ltd | CDE ↗ |
Catalogue holder records
70 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Nimodipine Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H10910081 | 2026/10/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Dapoxetine Hydrochloride Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20265706 | 2026/08/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapagliflozin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20265670 | 2026/08/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapagliflozin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20265648 | 2026/08/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sevelamer Carbonate Powder for oral suspension | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20264551 | 2026/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sevelamer Carbonate Powder for oral suspension | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20264552 | 2026/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Phenobarbital Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020639 | 2026/05/13 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Bumetanide Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263885 | 2026/04/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Bumetanide Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263884 | 2026/04/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Multiple Electrolyte Additive For Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20263780 | 2026/03/31 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Entacapone Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20263454 | 2026/02/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Citicoline Sodium Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H19993062 | 2026/02/25 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Glucosamine Sulfate Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20263303 | 2026/02/02 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Phloroglucinol Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256347 | 2025/12/22 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Valsartan Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20256391 | 2025/12/22 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Oseltamivir Phosphate For Oral Suspension | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20256303 | 2025/12/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Piracetam Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37023216 | 2025/11/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020374 | 2025/11/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Bisoprolol Fumarate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255640 | 2025/09/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Bisoprolol Fumarate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255641 | 2025/09/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sacubitril Valsartan Sodium Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255131 | 2025/08/19 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ethyl Iosapentate Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254286 | 2025/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Pu De Pharma Co., Ltd. romanized | 国药准字H20254347 | 2025/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ethyl Iosapentate Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254287 | 2025/05/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Aspirin Enteric-coated Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20258068 | 2025/04/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Aminophylline Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020630 | 2025/04/09 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Tadalafil Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20258045 | 2025/03/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20258046 | 2025/03/28 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pentazocine Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20253528 | 2025/03/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Empagliflozin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20253201 | 2025/01/14 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tramadol Hydrochloride SR Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H19990062 | 2025/01/06 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Calcium Gluconate Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020733 | 2024/10/30 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Peramivir Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 国药准字H20244037 | 2024/06/18 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pregabalin Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243977 | 2024/06/11 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pregabalin Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243976 | 2024/06/11 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Citicoline Sodium Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20247114 | 2024/05/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Naloxone Hydrochloride Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20055762 | 2024/05/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Naloxone Hydrochloride Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20055763 | 2024/05/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Naloxone Hydrochloride Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20055761 | 2024/05/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Sodium Bicarbonate Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20227054 | 2024/05/23 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Escitalopram Oxalate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20243682 | 2024/05/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ibuprofen Sustained Release Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243295 | 2024/03/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Memantine Hydrochloride Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized | 国药准字H20243056 | 2024/01/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20234614 | 2023/12/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Apixaban Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20234292 | 2023/10/12 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Alogliptin Benzoate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20234021 | 2023/08/08 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Alogliptin Benzoate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20234022 | 2023/08/08 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Rabeprazole Sodium Enteric-coated Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20237076 | 2023/07/11 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Dobutamine Hydrochloride Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20237073 | 2023/07/05 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Rabeprazole Sodium Enteric-coated Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20080683 | 2023/06/08 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Valsartan and Amlodipine Tablets（I） | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20233538 | 2023/05/12 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Meloxicam Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20010002 | 2023/03/23 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Sevelamer Carbonate Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20233203 | 2023/02/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Piracetam Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37023217 | 2023/02/01 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Furosemide Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020293 | 2022/10/08 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Compound Sulfamethoxazole Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020649 | 2021/11/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Aminophylline Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37023481 | 2021/11/04 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Atorvastatin Calcium Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Hangzhou Min Sheng Bin Jiang Pharmaceutical Co., Ltd. romanized | 国药准字H20213751 | 2021/09/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Clindamycin Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20030302 | 2021/09/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Clindamycin Injection | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H10950019 | 2021/09/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Cefalexin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020258 | 2020/12/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Cefalexin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020259 | 2020/12/15 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Clarithromycin Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H19990225 | 2020/06/13 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Cefalexin Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020702 | 2020/01/20 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Cefalexin Capsules | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020701 | 2020/01/20 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Captopril Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020331 | 2019/11/07 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H37020707 | 2019/09/09 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Glimepiride Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20061256 | 2019/04/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Glimepiride Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20010571 | 2019/04/28 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Sildenafil Citrate Oral Disintegrating Tablets | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255352 | 2025/09/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.
API registrations
87 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20260000504 | I | 2026/08/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250001500 | I | 2026/03/30 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250001501 | I | 2026/02/26 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250001403 | I | 2026/01/05 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250000995 | I | 2025/09/25 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20250000704 | I | 2025/07/11 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20240000681 | A | 2026/05/08 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230001352 | A | 2025/11/26 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230001353 | A | 2025/11/14 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230001014 | A | 2025/06/26 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230000980 | A | 2025/06/09 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20230000457 | A | 2025/05/15 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20220001328 | A | 2025/09/17 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20220001327 | A | 2024/09/02 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20220000275 | A | 2024/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210001232 | A | 2023/10/09 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210001145 | A | 2023/06/16 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210001073 | I | 2022/08/03 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210000840 | A | 2026/09/03 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210000306 | A | 2024/06/08 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20200001357 | A | 2023/03/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20200000903 | A | 2022/10/18 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20200000748 | A | 2026/08/26 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20200000351 | A | 2022/10/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009887 | A | 2024/06/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009852 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009756 | A | 2026/02/14 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009437 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009436 | A | 2025/02/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009435 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009434 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009433 | A | 2025/02/11 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009432 | A | 2025/02/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009431 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009430 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009429 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009428 | A | 2025/02/11 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009427 | A | 2025/09/18 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009426 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009425 | A | 2025/02/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009424 | A | 2025/02/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009423 | A | 2025/01/25 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009361 | A | 2024/09/03 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190008433 | A | 2025/02/09 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190007927 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190007733 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190006413 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190003686 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190003685 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190003671 | A | 2024/10/24 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001821 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001819 | A | 2025/04/25 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001817 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001816 | A | 2025/02/11 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001815 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001809 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001805 | A | 2025/03/06 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001803 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001802 | A | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001796 | A | 2025/04/22 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190001792 | A | 2025/02/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000619 | I | 2019/07/31 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000602 | I | 2019/07/11 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000483 | I | 2019/07/05 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000149 | I | 2019/05/09 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000328 | A | 2019/05/09 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000138 | I | 2019/03/20 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190000053 | A | 2019/02/03 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001694 | I | 2019/01/14 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001389 | I | 2018/11/30 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001435 | I | 2018/11/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001434 | I | 2018/11/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001391 | I | 2018/11/08 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001390 | I | 2018/11/13 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001326 | I | 2018/10/26 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001052 | I | 2018/08/22 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180001074 | A | 2024/09/04 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20180000981 | I | 2018/08/07 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001890 | I | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001889 | A | 2024/12/06 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001449 | A | 2024/02/08 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001291 | I | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000961 | I | — | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000745 | A | 2025/04/28 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000660 | A | 2025/02/12 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000376 | A | 2025/02/27 | CDE ↗ |
| No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170000237 | A | 2024/02/08 | CDE ↗ |
Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.
Co-applicant records
11 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/11 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Oseltamivir Phosphate Capsules | CYHB2502364 | Supplement | 2025/11/18 | Beijing Jia Lin Pharma Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Oseltamivir Phosphate Capsules | CYHB2502363 | Supplement | 2025/11/18 | Beijing Jia Lin Pharma Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2402065 | Supplement | 2024/12/05 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2400496 | Supplement | 2024/04/13 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | JTH2400009 | Not stated by source | 2024/01/20 | M/s. Biophore India Pharmaceuticals Pvt. Ltd.; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2302364 | Supplement | 2023/10/25 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2350750 | Supplement | 2023/10/10 | Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CXHL2300258 | New drug | 2023/03/01 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Oseltamivir Phosphate Capsules | CYHS2202047 | Generic | 2022/12/09 | Nanjing Dao Qun Pharmaceuticals Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| Oseltamivir Phosphate Capsules | CYHS2202046 | Generic | 2022/12/09 | Nanjing Dao Qun Pharmaceuticals Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
| No verified English name | CYHB2100150 | Supplement | 2021/01/21 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | CDE ↗ |
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/11 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/11 06:38
- Full API register
- Last successful update: 2026/11/11 06:40
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete
First index-page publication dates: — to —; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
Listed by the company name as recorded in the source, without merging affiliated entities.
This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.