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Matched- Active ingredients (original)
- MEMANTINE HYDROCHLORIDE
- 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 approval2003/10/16
ANDA applications26
RLD applicantABBVIE 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 |
|---|---|---|---|---|---|---|---|---|---|
| A079225-001 | MEMANTINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/01/30 | N / N | DISCONTINUED | openFDA ↗ |
| A079225-002 | MEMANTINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/01/30 | N / N | DISCONTINUED | openFDA ↗ |
| A090041-001 | MEMANTINE HYDROCHLORIDE | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/04/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090041-002 | MEMANTINE HYDROCHLORIDE | AMNEAL PHARMACEUTICALS OF NEW YORK LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/04/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090043-001 | MEMANTINE HYDROCHLORIDE | UPSHER SMITH LABORATORIES LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/07/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090043-002 | MEMANTINE HYDROCHLORIDE | UPSHER SMITH LABORATORIES LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/07/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090044-001 | MEMANTINE HYDROCHLORIDE | ORBION PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2012/03/12 | N / N | DISCONTINUED | openFDA ↗ |
| A090044-002 | MEMANTINE HYDROCHLORIDE | ORBION PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2012/03/12 | N / N | DISCONTINUED | openFDA ↗ |
| A090048-001 | MEMANTINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2010/04/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090048-002 | MEMANTINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2010/04/14 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090051-001 | MEMANTINE HYDROCHLORIDE | LUPIN LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/04/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090051-002 | MEMANTINE HYDROCHLORIDE | LUPIN LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/04/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090052-001 | MEMANTINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2011/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A090052-002 | MEMANTINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2011/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A090058-001 | MEMANTINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2010/05/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090058-002 | MEMANTINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2010/05/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090073-001 | MEMANTINE HYDROCHLORIDE | PHARMAZONE | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/09/04 | N / N | DISCONTINUED | openFDA ↗ |
| A090073-002 | MEMANTINE HYDROCHLORIDE | PHARMAZONE | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/09/04 | N / N | DISCONTINUED | openFDA ↗ |
| A090244-001 | MEMANTINE HYDROCHLORIDE | CHARTWELL LIFE MOLECULES LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2018/07/11 | N / N | DISCONTINUED | openFDA ↗ |
| A090244-002 | MEMANTINE HYDROCHLORIDE | CHARTWELL LIFE MOLECULES LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2018/07/11 | N / N | DISCONTINUED | openFDA ↗ |
| A090961-001 | MEMANTINE HYDROCHLORIDE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2017/07/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090961-002 | MEMANTINE HYDROCHLORIDE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2017/07/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091585-001 | MEMANTINE HYDROCHLORIDE | JUBILANT GENERICS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | DISCONTINUED | openFDA ↗ |
| A091585-002 | MEMANTINE HYDROCHLORIDE | JUBILANT GENERICS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | DISCONTINUED | openFDA ↗ |
| A200022-001 | MEMANTINE HYDROCHLORIDE | UNICHEM LABORATORIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200022-002 | MEMANTINE HYDROCHLORIDE | UNICHEM LABORATORIES LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200155-001 | MEMANTINE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | DISCONTINUED | openFDA ↗ |
| A200155-002 | MEMANTINE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | DISCONTINUED | openFDA ↗ |
| A200891-001 | MEMANTINE HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200891-002 | MEMANTINE HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202350-001 | MEMANTINE HYDROCHLORIDE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2017/05/23 | N / N | DISCONTINUED | openFDA ↗ |
| A202350-002 | MEMANTINE HYDROCHLORIDE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2017/05/23 | N / N | DISCONTINUED | openFDA ↗ |
| A202840-001 | MEMANTINE HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202840-002 | MEMANTINE HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203175-001 | MEMANTINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203175-002 | MEMANTINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/10/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204389-001 | MEMANTINE HYDROCHLORIDE | HETERO LABS LTD UNIT V | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2022/09/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204389-002 | MEMANTINE HYDROCHLORIDE | HETERO LABS LTD UNIT V | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2022/09/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206528-001 | MEMANTINE HYDROCHLORIDE | AJANTA PHARMA LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/11/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206528-002 | MEMANTINE HYDROCHLORIDE | AJANTA PHARMA LTD | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/11/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206855-001 | MEMANTINE HYDROCHLORIDE | PURACAP PHARMACEUTICAL LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2015/11/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206855-002 | MEMANTINE HYDROCHLORIDE | PURACAP PHARMACEUTICAL LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2015/11/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207236-001 | MEMANTINE HYDROCHLORIDE | LANNETT CO INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2016/11/10 | N / N | DISCONTINUED | openFDA ↗ |
| A207236-002 | MEMANTINE HYDROCHLORIDE | LANNETT CO INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2016/11/10 | N / N | DISCONTINUED | openFDA ↗ |
| A208173-001 | MEMANTINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2020/02/28 | N / N | DISCONTINUED | openFDA ↗ |
| A208173-002 | MEMANTINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2020/02/28 | N / N | DISCONTINUED | openFDA ↗ |
| A209527-001 | MEMANTINE HYDROCHLORIDE | SOMERSET THERAPEUTICS LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2018/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209527-002 | MEMANTINE HYDROCHLORIDE | SOMERSET THERAPEUTICS LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2018/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210587-001 | MEMANTINE HYDROCHLORIDE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2020/12/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210587-002 | MEMANTINE HYDROCHLORIDE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2020/12/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212947-001 | MEMANTINE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG | 2020/04/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212947-002 | MEMANTINE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG | 2020/04/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021487-001 | NAMENDA | ABBVIE INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/10/16 | Y / N | DISCONTINUED | openFDA ↗ |
| N021487-002 | NAMENDA | ABBVIE INC | TABLET | ORAL | MEMANTINE HYDROCHLORIDE: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/10/16 | 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 29
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | 国药准字H2025610310mg | 2025/12/03 | Official source ↗ |
| Sichuan Shang Rui Biopharmaceuticals Co., Ltd. romanized | 国药准字H2025574110mg | 2025/10/21 | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H2025569210mg | 2025/10/14 | Official source ↗ |
| Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024919410mg | 2024/10/29 | Official source ↗ |
| Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024495610mg | 2024/09/19 | Official source ↗ |
| Shaanxi Tian Di Ren He Pharma Co., Ltd. romanized | 国药准字H2024465810mg | 2024/08/20 | Official source ↗ |
| Shaanxi Tian Di Ren He Pharma Co., Ltd. romanized | 国药准字H2024465920mg | 2024/08/20 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H2024305610mg | 2024/01/16 | Official source ↗ |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | 国药准字H2023400420mg | 2023/08/01 | Official source ↗ |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | 国药准字H2023400310mg | 2023/08/01 | Official source ↗ |
| Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2023359210mg | 2023/05/26 | Official source ↗ |
| Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 国药准字H2023354510mg | 2023/05/12 | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | 2023/03/07 | Official source ↗ |
| Dr. Reddy’s Laboratories Limited | 国药准字HJ2022009210mg | 2022/11/22 | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized | 国药准字H2022385510mg | 2022/11/15 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2022381610mg | 2022/11/08 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2022381715mg | 2022/11/08 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H202238155mg | 2022/11/08 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2022381820mg | 2022/11/08 | Official source ↗ |
| Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2022358510mg | 2022/08/10 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2022340610mg | 2022/06/16 | Official source ↗ |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H2021393010mg | 2021/12/08 | Official source ↗ |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H202139315mg | 2021/12/08 | Official source ↗ |
| Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | 国药准字H2021372910mg | 2021/09/13 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | 2021/08/25 | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H2021359610mg | 2021/07/20 | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | 2021/05/21 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | 2021/02/02 | Official source ↗ |
| Pu Luo Pharma Co., Ltd. romanized | 国药准字H2021308010mg | 2021/01/30 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H2020355510mg | 2020/11/04 | Official source ↗ |
| Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized | 国药准字H2020334910mg | 2020/07/21 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202033205mg | 2020/07/16 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331910mg | 2020/07/16 | Official source ↗ |
| Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | 国药准字H2020313410mg | 2020/03/31 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H2020301610mg | 2020/01/21 | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | 2019/09/17 | Official source ↗ |
NHSA approval numbers 34
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | 国药准字H2023400310mg | — | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H2020334910mg | — | Official source ↗ |
| Chongqing Rui En Pharmaceuticals Co., Ltd. romanized | 国药准字H2023359210mg | — | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | — | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized | 国药准字H2022385510mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202033205mg | — | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | 国药准字H2025610310mg | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H2021359610mg | — | Official source ↗ |
| Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | 国药准字H2021372910mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H2024305610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2022358510mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2021308010mg | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H2020301610mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H2025569210mg | — | Official source ↗ |
| Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024495610mg | — | Official source ↗ |
| Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024919410mg | — | Official source ↗ |
| Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | 国药准字H2020313410mg | — | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | 国药准字H2020355510mg | — | Official source ↗ |
| Dr.Reddy's Laboratories Limited | 国药准字HJ2022009210mg | — | Official source ↗ |
| H. Lundbeck A/S | 国药准字HJ2012026810mg | — | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2022340610mg | — | Official source ↗ |
| Sichuan Shang Rui Biopharmaceuticals Co., Ltd. romanized | 国药准字H2025574110mg | — | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H2021393010mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2026341410mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Chongqing Rui En Pharmaceuticals Co., Ltd. romanized | 国药准字H2023359210mg | — | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H2021359610mg | — | Official source ↗ |
| Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | 国药准字H2021372910mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2021308010mg | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H2020301610mg | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H2025569210mg | — | Official source ↗ |
| Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024495610mg | — | Official source ↗ |
| Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024919410mg | — | Official source ↗ |
| H.Lundbeck A/S | H2013037210mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2026341410mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Chongqing Rui En Pharmaceuticals Co., Ltd. romanized | 国药准字H2023359210mg | — | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | — | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H2021359610mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2021308010mg | — | Official source ↗ |
| Hainan Lin Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024495610mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2026341410mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2021308010mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2026341410mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H2019326810mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | 国药准字H2023325610mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2021365710mg | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2021308010mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H2021311910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H2013008610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H202238155mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331910mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381610mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381715mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
| Anhui Yu Heng Bio Technology Co., Ltd. romanized | 国药准字H2022381820mg | — | Official source ↗ |
Under review 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600773 | 2026/04/02 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2600142 | 2026/01/10 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | CYHS2600773 | 2026/04/02 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2600142 | 2026/01/10 | Official source ↗ |
API companies with A status 37
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| OLON S.p.A. | Y20240001170 | 2026/09/01 | Official source ↗ |
| Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20240000483 | 2025/12/18 | Official source ↗ |
| Shenyang Tian Bang Pharma Co., Ltd. romanized | Y20230001221 | 2025/11/19 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20230001198 | 2025/11/26 | Official source ↗ |
| Anhui Pu Li Pharma Co., Ltd. romanized | Y20230000102 | 2024/09/10 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | Y20220000214 | 2023/12/05 | Official source ↗ |
| COHANCE LIFESCIENCES LIMITED | Y20210000513 | 2025/06/03 | Official source ↗ |
| Shandong Hai You Fu Rui Da Pharmaceutical Co., Ltd. romanized | Y20210000467 | 2026/03/18 | Official source ↗ |
| Anhui Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20210000550 | 2026/01/01 | Official source ↗ |
| Unichem Laboratories Limited | Y20210000402 | 2023/08/11 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20200001047 | 2022/10/28 | Official source ↗ |
| Zhejiang Shang Tai Biopharmaceutical Co., Ltd. romanized | Y20200001118 | 2026/09/17 | Official source ↗ |
| Dr.Reddy's Laboratories Ltd. | Y20200000988 | 2023/05/01 | Official source ↗ |
| Sichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanized | Y20200001003 | 2023/07/24 | Official source ↗ |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | Y20190021531 | 2023/07/28 | Official source ↗ |
| Matrix Pharmacorp Private Limited | Y20190001079 | 2026/05/20 | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190007101 | 2023/03/24 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190006826 | — | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190006801 | 2023/03/24 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190000580 | 2026/06/12 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | Y20190000706 | 2025/06/25 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | Y20190000110 | 2025/07/29 | Official source ↗ |
| MSN Pharmachem Private Limited | Y20180001481 | 2025/06/17 | Official source ↗ |
| Anhui Hua Chen Pharmaceutical Co., Ltd. romanized | Y20180000939 | 2025/01/18 | Official source ↗ |
| Hetero Drugs Limited (Unit-IX) | Y20170001630 | 2023/02/17 | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Chemical Pharmaceutical Factory romanized | Y20170001443 | 2024/06/06 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20170001437 | 2022/10/19 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Y20170001394 | 2024/01/03 | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20170001383 | 2024/08/03 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20170001336 | 2023/08/11 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | Y20170001330 | 2024/12/18 | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | Y20170001254 | 2023/10/27 | Official source ↗ |
| Shandong Luo Xin Pharma Group Heng Xin Pharma Co., Ltd. romanized | Y20170001145 | 2024/11/29 | Official source ↗ |
| MEGAFINE PHARMA (P) LTD. | Y20170001045 | 2024/12/11 | Official source ↗ |
| Alembic Pharmaceuticals Limited | Y20170000855 | 2024/11/07 | Official source ↗ |
| TAPI Croatia Industries Ltd. | Y20170000828 | 2025/06/11 | Official source ↗ |
| AMSA-ANONIMA MATERIE SINTETICHE & AFFINI S.P.A. | Y20170000608 | 2025/04/29 | 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 ↗ · 39-35 · 2021/03/03
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