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Matched- Active ingredients (original)
- LIDOCAINE · PRILOCAINE
- Dosage form (original)
- CREAM
- Route (original)
- TOPICAL
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 approval1992/12/30
ANDA applications8
RLD applicantTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Currently marketed products: 5 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076290-001 | LIDOCAINE AND PRILOCAINE | HIKMA PHARMACEUTICALS USA INC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2003/09/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076320-001 | LIDOCAINE AND PRILOCAINE | ENCUBE ETHICALS PRIVATE LTD | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2003/08/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076453-001 | LIDOCAINE AND PRILOCAINE | FOUGERA PHARMACEUTICALS INC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2003/08/18 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205887-001 | LIDOCAINE AND PRILOCAINE | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2018/06/29 | N / N | DISCONTINUED | openFDA ↗ |
| A212482-001 | LIDOCAINE AND PRILOCAINE | PADAGIS US LLC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2021/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213253-001 | LIDOCAINE AND PRILOCAINE | CHARTWELL RX SCIENCES LLC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2020/09/21 | N / N | DISCONTINUED | openFDA ↗ |
| A213923-001 | LIDOCAINE AND PRILOCAINE | ALEMBIC PHARMACEUTICALS LTD | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2022/04/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219120-001 | LIDOCAINE AND PRILOCAINE | ZYDUS LIFESCIENCES LTD | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% | 2024/12/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019941-001 | EMLA | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC | CREAM | TOPICAL | LIDOCAINE: 2.5% PRILOCAINE: 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1992/12/30 | 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 41
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20254428See source | — | Official source ↗ |
| Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | 国药准字H20265664See source | — | Official source ↗ |
| Suzhou Erye Pharmaceutical Co., Ltd | 国药准字H20253227See source | — | Official source ↗ |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20253274See source | — | Official source ↗ |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H20249681See source | — | Official source ↗ |
| Guangdong Ke Hong Pharma Co., Ltd. romanized | 国药准字H20253151See source | — | Official source ↗ |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H20253865See source | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255987See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253006See source | — | Official source ↗ |
| Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20249104See source | — | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20253044See source | — | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 国药准字H20249736See source | — | Official source ↗ |
| Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20254771See source | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H20255207See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254628See source | — | Official source ↗ |
| Aspen Pharmacare Australia Pty Ltd | H20100154See source | — | Official source ↗ |
| Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20233544See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20255211See source | — | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20255085See source | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20265498See source | — | Official source ↗ |
| Jilin Sheng Jin Pai Ge Pharma Co., Ltd. romanized | 国药准字H20233629See source | — | Official source ↗ |
| Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20265342See source | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20264611See source | — | Official source ↗ |
| Jing Shi (Hangzhou) Pharma Co., Ltd. romanized | 国药准字H20253898See source | — | Official source ↗ |
| Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized | 国药准字H20249685See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253877See source | — | Official source ↗ |
| Ningbo Mei Shu Pharma Co., Ltd. romanized | 国药准字H20256240See source | — | Official source ↗ |
| Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253758See source | — | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263664See source | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253517See source | — | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249680See source | — | Official source ↗ |
| Hainan He Rui Da Pharma Co., Ltd. romanized | 国药准字H20249103See source | — | Official source ↗ |
| Name not romanized | 国药准字H20249822See source | — | Official source ↗ |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H20249681See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253006See source | — | Official source ↗ |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 国药准字H20249736See source | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H20255207See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253877See source | — | Official source ↗ |
| Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253758See source | — | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263664See source | — | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249680See source | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253006See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253877See source | — | Official source ↗ |
| Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253758See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253877See source | — | Official source ↗ |
| Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253758See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253877See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20254749See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20253362See source | — | Official source ↗ |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H20269044See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20233544See source | — | Official source ↗ |
| Jilin Sheng Jin Pai Ge Pharma Co., Ltd. romanized | 国药准字H20233629See source | — | Official source ↗ |
| Jing Shi (Hangzhou) Pharma Co., Ltd. romanized | 国药准字H20258294See source | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269191See source | — | Official source ↗ |
| Hainan He Rui Da Pharma Co., Ltd. romanized | 国药准字H20249103See source | — | Official source ↗ |
| Name not romanized | 国药准字H20269008See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269191See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269191See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20269191See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269015See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20233544See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20269016See source | — | Official source ↗ |
| Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20233544See source | — | Official source ↗ |
Under review 24
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2502722 | 2025/07/30 | Official source ↗ |
| Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHB2601490 | 2026/08/04 | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHB2501640 | 2025/08/19 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHB2601334 | 2026/07/14 | Official source ↗ |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHB2501935 | 2025/09/29 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHB2601917 | 2026/10/21 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHB2601716 | 2026/09/10 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHB2601715 | 2026/09/10 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHB2601714 | 2026/09/10 | Official source ↗ |
| Hainan He Rui Da Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHB2601198 | 2026/06/26 | Official source ↗ |
| Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2601330 | 2026/06/08 | Official source ↗ |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHB2601048 | 2026/06/04 | Official source ↗ |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHB2601047 | 2026/06/04 | Official source ↗ |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized | CYHS2600718 | 2026/03/26 | Official source ↗ |
| Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized | CYHS2504321 | 2025/12/19 | Official source ↗ |
| Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized | CYHS2504320 | 2025/12/19 | Official source ↗ |
| Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized | CYHS2504319 | 2025/12/19 | Official source ↗ |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | CYHS2504234 | 2025/12/10 | Official source ↗ |
| Hebei Hua Chen Pharma Group Co., Ltd. romanized | CYHS2502695 | 2025/07/25 | Official source ↗ |
| Hebei Hua Chen Pharma Group Co., Ltd. romanized | CYHS2502694 | 2025/07/25 | Official source ↗ |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2602610 | 2026/10/23 | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | CYHB2601983 | 2026/10/29 | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | CYHB2601982 | 2026/10/29 | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | CYHB2601981 | 2026/10/29 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanized | CYHS2601330 | 2026/06/08 | Official source ↗ |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized | CYHS2600718 | 2026/03/26 | Official source ↗ |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2602610 | 2026/10/23 | Official source ↗ |
API companies with A status 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded 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.
Formulation crosswalk to CREAM / TOPICAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-057. Chinese Pharmacopoeia general chapter 0109
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 34-11 · 2020/12/21
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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