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Matched- Active ingredients (original)
- DOXYCYCLINE HYCLATE
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approvalApproved before 1982
ANDA applications40
RLD applicantCHARTWELL PHARMA NDA B2 HOLDINGS / CHARTWELL RX SCIENCES LLC / GALDERMA LABORATORIES LP / PFIZER LABORATORIES DIV PFIZER INC
Currently marketed products: 32 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A062269-002 | DOXYCYCLINE HYCLATE | EPIC PHARMA LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1982/11/08 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062269-003 | DOXYCYCLINE HYCLATE | EPIC PHARMA LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 50MG BASE | 1983/10/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062391-001 | DOXYCYCLINE HYCLATE | MUTUAL PHARMACEUTICAL CO INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1982/09/30 | N / N | DISCONTINUED | openFDA ↗ |
| A062392-001 | DOXYCYCLINE HYCLATE | WATSON LABORATORIES INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 50MG BASE | 1983/03/31 | N / N | DISCONTINUED | openFDA ↗ |
| A062392-002 | DOXYCYCLINE HYCLATE | WATSON LABORATORIES INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1983/03/31 | N / N | DISCONTINUED | openFDA ↗ |
| A062421-001 | DOXYCYCLINE HYCLATE | ACTAVIS LABORATORIES FL INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1983/02/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062432-001 | DOXYCYCLINE HYCLATE | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1983/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A062462-001 | DOXYCYCLINE HYCLATE | HEATHER DRUG CO INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1983/05/11 | N / N | DISCONTINUED | openFDA ↗ |
| A062494-001 | DOXYCYCLINE HYCLATE | SUPERPHARM CORP | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1985/02/20 | N / N | DISCONTINUED | openFDA ↗ |
| A062505-001 | DOXYCYCLINE HYCLATE | CHARTWELL SCHEDULED LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1984/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062505-002 | DOXYCYCLINE HYCLATE | CHARTWELL SCHEDULED LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 50MG BASE | 2021/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062538-001 | DOXYCYCLINE HYCLATE | STRIDES PHARMA INTERNATIONAL AG | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1986/04/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062538-002 | DOXYCYCLINE HYCLATE | STRIDES PHARMA INTERNATIONAL AG | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 50MG BASE | 2025/11/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062581-001 | DOXY-LEMMON | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1985/03/15 | N / N | DISCONTINUED | openFDA ↗ |
| A062593-001 | DOXYCYCLINE HYCLATE | WARNER CHILCOTT DIV WARNER LAMBERT CO | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1985/08/28 | N / N | DISCONTINUED | openFDA ↗ |
| A062677-001 | DOXYCYCLINE HYCLATE | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1986/07/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A062764-001 | DOXYCYCLINE HYCLATE | INTERPHARM INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 1988/09/02 | N / N | DISCONTINUED | openFDA ↗ |
| A065095-001 | DOXYCYCLINE HYCLATE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2003/07/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065134-001 | DOXYCYCLINE HYCLATE | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2005/05/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065163-001 | DOXYCYCLINE HYCLATE | HERITAGE PHARMA LABS INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2005/05/13 | N / N | DISCONTINUED | openFDA ↗ |
| A065182-001 | DOXYCYCLINE HYCLATE | EPIC PHARMA LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2005/05/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065277-001 | DOXYCYCLINE HYCLATE | CHARTWELL MOLECULAR HOLDINGS LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2005/11/10 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A065287-001 | DOXYCYCLINE HYCLATE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2006/02/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207558-001 | DOXYCYCLINE HYCLATE | NOVEL LABORATORIES INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2017/09/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207773-001 | DOXYCYCLINE HYCLATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2017/10/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208765-001 | DOXYCYCLINE HYCLATE | DR REDDYS LABORATORIES SA | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2017/06/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208765-002 | DOXYCYCLINE HYCLATE | DR REDDYS LABORATORIES SA | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2017/06/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208818-001 | DOXYCYCLINE HYCLATE | LUPIN LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2017/09/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208818-002 | DOXYCYCLINE HYCLATE | LUPIN LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2017/09/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209243-001 | DOXYCYCLINE HYCLATE | APOTEX INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2019/04/15 | N / N | DISCONTINUED | openFDA ↗ |
| A209243-002 | DOXYCYCLINE HYCLATE | APOTEX INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2019/04/15 | N / N | DISCONTINUED | openFDA ↗ |
| A209372-001 | DOXYCYCLINE HYCLATE | AMNEAL PHARMACEUTICALS CO GMBH | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2017/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A209372-002 | DOXYCYCLINE HYCLATE | AMNEAL PHARMACEUTICALS CO GMBH | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2017/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A209560-001 | DOXYCYCLINE HYCLATE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2024/04/15 | N / N | DISCONTINUED | openFDA ↗ |
| A209969-001 | DOXYCYCLINE HYCLATE | AVET LIFESCIENCES LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2018/11/09 | N / N | DISCONTINUED | openFDA ↗ |
| A209987-001 | DOXYCYCLINE HYCLATE | RISING PHARMA HOLDING INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2020/10/05 | N / N | DISCONTINUED | openFDA ↗ |
| A209987-002 | DOXYCYCLINE HYCLATE | RISING PHARMA HOLDING INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2020/10/05 | N / N | DISCONTINUED | openFDA ↗ |
| A210536-001 | DOXYCYCLINE HYCLATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2020/05/14 | N / N | DISCONTINUED | openFDA ↗ |
| A210536-002 | DOXYCYCLINE HYCLATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 50MG BASE | 2021/09/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210537-001 | DOXYCYCLINE HYCLATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE | 2020/03/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210664-001 | DOXYCYCLINE HYCLATE | ACELLA PHARMACEUTICALS LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2020/03/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211343-001 | DOXYCYCLINE HYCLATE | CHANGZHOU PHARMACEUTICAL FACTORY | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2019/10/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211418-001 | DOXYCYCLINE HYCLATE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2025/11/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211584-001 | DOXYCYCLINE HYCLATE | AJANTA PHARMA LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2020/06/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211584-002 | DOXYCYCLINE HYCLATE | AJANTA PHARMA LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2020/06/01 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211744-001 | DOXYCYCLINE HYCLATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2020/06/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211744-002 | DOXYCYCLINE HYCLATE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2020/06/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212487-001 | DOXYCYCLINE HYCLATE | QUAGEN PHARMACEUTICALS LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2022/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A213475-001 | DOXYCYCLINE HYCLATE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2021/03/10 | N / N | DISCONTINUED | openFDA ↗ |
| A214207-001 | DOXYCYCLINE HYCLATE | EPIC PHARMA LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2020/12/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214207-002 | DOXYCYCLINE HYCLATE | EPIC PHARMA LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2020/12/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214356-001 | DOXYCYCLINE HYCLATE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2024/04/15 | N / N | DISCONTINUED | openFDA ↗ |
| A214356-002 | DOXYCYCLINE HYCLATE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2024/04/15 | N / N | DISCONTINUED | openFDA ↗ |
| A216599-001 | DOXYCYCLINE HYCLATE | AMNEAL EU LTD | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2022/10/24 | N / N | DISCONTINUED | openFDA ↗ |
| N050533-001 | VIBRA-TABS | PFIZER LABORATORIES DIV PFIZER INC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N050783-001 | PERIOSTAT | GALDERMA LABORATORIES LP | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2001/02/02 | Y / N | DISCONTINUED | openFDA ↗ |
| N205931-001 | ACTICLATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 75MG BASE | 2014/07/25 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205931-002 | ACTICLATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 150MG BASE | 2014/07/25 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N209844-001 | LYMEPAK | CHARTWELL PHARMA NDA B2 HOLDINGS | TABLET | ORAL | DOXYCYCLINE HYCLATE: EQ 100MG BASE | 2018/06/15 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Shi Mo Xi Bio Technology Co., Ltd. romanized | 国药准字H20269241See source | 2026/09/29 | Official source ↗ |
| Guangzhou Shi Mo Xi Bio Technology Co., Ltd. romanized | 国药准字H44022831See source | 2026/09/29 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | 国药准字H20266127See source | 2026/09/29 | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263331See source | 2026/02/02 | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263332See source | 2026/02/02 | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | 2025/02/25 | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | 2025/02/25 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | 2022/03/30 | Official source ↗ |
NHSA approval numbers 56
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H44022263See source | — | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H44021610See source | — | Official source ↗ |
| Guangdong Hua Nan Pharma Group Co., Ltd. romanized | 国药准字H44025005See source | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44021882See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Guangdong Zhong Sheng Pharma Co., Ltd. romanized | 国药准字H44021455See source | — | Official source ↗ |
| Guangzhou Bai Yun Shan Guang Hua Pharmaceutical Co., Ltd. romanized | 国药准字H44020175See source | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H44022831See source | — | Official source ↗ |
| Li Zhu Group Li Min Pharmaceutical Factory romanized | 国药准字H44020593See source | — | Official source ↗ |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31021129See source | — | Official source ↗ |
| Hui Rui Pharmaceutical Co., Ltd. romanized | 国药准字H19993983See source | — | Official source ↗ |
| Jiangsu Lian Shui Pharmaceutical Co., Ltd. romanized | 国药准字H32023940See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | — | Official source ↗ |
| Jiangsu Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H32021227See source | — | Official source ↗ |
| Jiangsu Rui Nian Qian Jin Pharmaceutical Co., Ltd. romanized | 国药准字H32020684See source | — | Official source ↗ |
| Suzhou Hong Sen Pharma Co., Ltd. romanized | 国药准字H32020364See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20266127See source | — | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H420220020.1g | — | Official source ↗ |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H51022998See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H200647340.1g | — | Official source ↗ |
| Xian Di Sai Bio Pharma Co., Ltd. romanized | 国药准字H610208950.1g | — | Official source ↗ |
| Hebei Chang Tian Pharma Co., Ltd. romanized | 国药准字H13020640See source | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | 国药准字H13021945See source | — | Official source ↗ |
| Wan Bang De Pharmaceutical Group Co., Ltd. romanized | 国药准字H13022241See source | — | Official source ↗ |
| Da Tong Shi Li Qun Pharma Co., Ltd. romanized | 国药准字H14020498See source | — | Official source ↗ |
| An Yang Shi Hua An Pharma Co., Ltd. romanized | 国药准字H41020833See source | — | Official source ↗ |
| Shanghai An Ding Bio (Tang Yin) Pharma Co., Ltd. romanized | 国药准字H41021433See source | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41020347See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H41022128See source | — | Official source ↗ |
| Henan Da Xin Pharma Co., Ltd. romanized | 国药准字H41021958See source | — | Official source ↗ |
| Kai Feng Kang Nuo Pharma Co., Ltd. romanized | 国药准字H41023619See source | — | Official source ↗ |
| Jilin Wan Tong Pharma Group Mei He Pharma Co., Ltd. romanized | 国药准字H22023683See source | — | Official source ↗ |
| Haerbin Tai Hua Pharma Co., Ltd. romanized | 国药准字H19994039See source | — | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H37022402See source | — | Official source ↗ |
| Anhui Chang Jiang Pharma Co., Ltd. romanized | 国药准字H34021049See source | — | Official source ↗ |
| Fujian Sheng San Ming Tian Tai Pharmaceutical Co., Ltd. romanized | 国药准字H35020048See source | — | Official source ↗ |
| Jiangxi Qing Feng Pharma Co., Ltd. romanized | 国药准字H20143033See source | — | Official source ↗ |
| Jiangxi Xin Gan Jiang Pharma Co., Ltd. romanized | 国药准字H36020566See source | — | Official source ↗ |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H46020437See source | — | Official source ↗ |
| Gansu Lan Yao Pharma Co., Ltd. romanized | 国药准字H62020641See source | — | Official source ↗ |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H620201110.1g | — | Official source ↗ |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H41022128See source | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263331See source | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44021882See source | — | Official source ↗ |
| Guangdong Zhong Sheng Pharma Co., Ltd. romanized | 国药准字H44021455See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20266127See source | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | 国药准字H13021945See source | — | Official source ↗ |
| Da Tong Shi Li Qun Pharma Co., Ltd. romanized | 国药准字H14020498See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H41022128See source | — | Official source ↗ |
| Henan Da Xin Pharma Co., Ltd. romanized | 国药准字H41021958See source | — | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H37022403See source | — | Official source ↗ |
| Fujian Sheng San Ming Tian Tai Pharmaceutical Co., Ltd. romanized | 国药准字H35020048See source | — | Official source ↗ |
| Gansu Cheng Ji Bio Pharma Co., Ltd. romanized | 国药准字H620201110.1g | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263331See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20266127See source | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | 国药准字H13021945See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41022186See source | — | Official source ↗ |
| Henan Da Xin Pharma Co., Ltd. romanized | 国药准字H41021958See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20266127See source | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | 国药准字H13021945See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41022186See source | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | 国药准字H13021945See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Guangdong Hua Nan Pharma Group Co., Ltd. romanized | 国药准字H44025004See source | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44021881See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Guangzhou Bai Yun Shan Guang Hua Pharmaceutical Co., Ltd. romanized | 国药准字H44020431See source | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H44022831See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | — | Official source ↗ |
| Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H51022999See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H2006473350mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41020868See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020947See source | — | Official source ↗ |
| Henan Da Xin Pharma Co., Ltd. romanized | 国药准字H41021959See source | — | Official source ↗ |
| Jiangxi Qing Feng Pharma Co., Ltd. romanized | 国药准字H20143033See source | — | Official source ↗ |
| Jiangxi Xin Gan Jiang Pharma Co., Ltd. romanized | 国药准字H36020567See source | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263332See source | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44021881See source | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H44022831See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020947See source | — | Official source ↗ |
| Jiangxi Qing Feng Pharma Co., Ltd. romanized | 国药准字H20143033See source | — | Official source ↗ |
| Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263332See source | — | Official source ↗ |
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H44021881See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H200647340.1g | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H32021266See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H200647340.1g | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020946See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H200647340.1g | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41022186See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44023645See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | 国药准字H200647340.1g | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H41020947See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
| Te Yi Pharma Group Co., Ltd. romanized | 国药准字H44021106See source | — | Official source ↗ |
Under review 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2502969 | 2025/08/14 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2502968 | 2025/08/14 | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | CYHS2601459 | 2026/06/22 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601168 | 2026/05/18 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601167 | 2026/05/18 | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | CYHB2650110 | 2026/04/30 | Official source ↗ |
| Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized | CYHS2504388 | 2025/12/25 | Official source ↗ |
| Hua Zhong Pharma Co., Ltd. romanized | CYHS2503937 | 2025/11/13 | Official source ↗ |
| Chengdu Shuo De Pharma Co., Ltd. romanized | CYHS2503512 | 2025/09/25 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized; Jiangxi Qing Feng Pharma Co., Ltd. romanized | CYHB2602003 | 2026/11/04 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | CYHS2601459 | 2026/06/22 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601168 | 2026/05/18 | Official source ↗ |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2601167 | 2026/05/18 | Official source ↗ |
API companies with A status 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20240001089 | 2026/08/15 | Official source ↗ |
| HOVIONE PHARMASCIENCE LIMITED | Y20220000451 | 2026/05/20 | Official source ↗ |
| Shanghai Qing Ping Pharma Co., Ltd. romanized | Y20190006582 | 2026/01/31 | Official source ↗ |
| Kun Shandong Fang Pharma Co., Ltd. romanized | Y20190006560 | — | Official source ↗ |
| Shijiazhuang Hua Shu Shan He Pharma Co., Ltd. romanized | Y20190006021 | — | Official source ↗ |
| Hebei Dong Feng Pharma Co., Ltd. romanized | Y20190005098 | 2025/02/09 | Official source ↗ |
| Suzhou Di Wu Pharmaceutical Factory Co., Ltd. romanized | Y20190005068 | — | Official source ↗ |
| Yan Cheng Su Hai Pharmaceutical Co., Ltd. romanized | Y20190004892 | 2025/07/18 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20190004505 | 2025/07/09 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190004072 | 2025/07/30 | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190002589 | 2024/09/11 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Y20190002114 | 2025/01/23 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 7-79 · 2017/07/27
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