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US$200
Billed every month
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Matched- Active ingredients (original)
- LOSARTAN POTASSIUM
- 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 approval1995/04/14
ANDA applications25
RLD applicantORGANON LLC A SUB OF ORGANON AND CO
Currently marketed products: 51 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076958-001 | LOSARTAN POTASSIUM | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A076958-002 | LOSARTAN POTASSIUM | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A076958-003 | LOSARTAN POTASSIUM | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077424-001 | LOSARTAN POTASSIUM | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077424-002 | LOSARTAN POTASSIUM | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077424-003 | LOSARTAN POTASSIUM | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077459-001 | LOSARTAN POTASSIUM | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077459-002 | LOSARTAN POTASSIUM | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077459-003 | LOSARTAN POTASSIUM | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A078232-001 | LOSARTAN POTASSIUM | LUPIN LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078232-002 | LOSARTAN POTASSIUM | LUPIN LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078232-003 | LOSARTAN POTASSIUM | LUPIN LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078243-001 | LOSARTAN POTASSIUM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078243-002 | LOSARTAN POTASSIUM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078243-003 | LOSARTAN POTASSIUM | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090083-001 | LOSARTAN POTASSIUM | AUROBINDO PHARMA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090083-002 | LOSARTAN POTASSIUM | AUROBINDO PHARMA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090083-003 | LOSARTAN POTASSIUM | AUROBINDO PHARMA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090382-001 | LOSARTAN POTASSIUM | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090382-002 | LOSARTAN POTASSIUM | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090382-003 | LOSARTAN POTASSIUM | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090428-001 | LOSARTAN POTASSIUM | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090428-002 | LOSARTAN POTASSIUM | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090428-003 | LOSARTAN POTASSIUM | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090467-001 | LOSARTAN POTASSIUM | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A090467-002 | LOSARTAN POTASSIUM | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A090467-003 | LOSARTAN POTASSIUM | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A090544-001 | LOSARTAN POTASSIUM | AIPING PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090544-002 | LOSARTAN POTASSIUM | AIPING PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090544-003 | LOSARTAN POTASSIUM | AIPING PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090790-001 | LOSARTAN POTASSIUM | APOTEX CORP | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A090790-002 | LOSARTAN POTASSIUM | APOTEX CORP | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A090790-003 | LOSARTAN POTASSIUM | APOTEX CORP | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091129-001 | LOSARTAN POTASSIUM | WATSON LABORATORIES INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091129-002 | LOSARTAN POTASSIUM | WATSON LABORATORIES INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091129-003 | LOSARTAN POTASSIUM | WATSON LABORATORIES INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091497-001 | LOSARTAN POTASSIUM | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2011/06/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091497-002 | LOSARTAN POTASSIUM | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2011/06/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091497-003 | LOSARTAN POTASSIUM | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2011/06/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091541-001 | LOSARTAN POTASSIUM | MICRO LABS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2012/09/24 | N / N | DISCONTINUED | openFDA ↗ |
| A091541-002 | LOSARTAN POTASSIUM | MICRO LABS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2012/09/24 | N / N | DISCONTINUED | openFDA ↗ |
| A091541-003 | LOSARTAN POTASSIUM | MICRO LABS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2012/09/24 | N / N | DISCONTINUED | openFDA ↗ |
| A091590-001 | LOSARTAN POTASSIUM | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091590-002 | LOSARTAN POTASSIUM | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091590-003 | LOSARTAN POTASSIUM | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2010/10/06 | N / N | DISCONTINUED | openFDA ↗ |
| A200290-001 | LOSARTAN POTASSIUM | IPCA LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2013/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A200290-002 | LOSARTAN POTASSIUM | IPCA LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2013/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A200290-003 | LOSARTAN POTASSIUM | IPCA LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2013/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A201170-001 | LOSARTAN POTASSIUM | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2012/09/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201170-002 | LOSARTAN POTASSIUM | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2012/09/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201170-003 | LOSARTAN POTASSIUM | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2012/09/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202230-001 | LOSARTAN POTASSIUM | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2012/05/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202230-002 | LOSARTAN POTASSIUM | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2012/05/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202230-003 | LOSARTAN POTASSIUM | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2012/05/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203030-001 | LOSARTAN POTASSIUM | UNICHEM LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2015/10/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203030-002 | LOSARTAN POTASSIUM | UNICHEM LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2015/10/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203030-003 | LOSARTAN POTASSIUM | UNICHEM LABORATORIES LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2015/10/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203835-001 | LOSARTAN POTASSIUM | HETERO LABS LTD UNIT V | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2015/08/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203835-002 | LOSARTAN POTASSIUM | HETERO LABS LTD UNIT V | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2015/08/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203835-003 | LOSARTAN POTASSIUM | HETERO LABS LTD UNIT V | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2015/08/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204795-001 | LOSARTAN POTASSIUM | HISUN PHARMACEUTICAL HANGZHOU CO LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2019/04/04 | N / N | DISCONTINUED | openFDA ↗ |
| A204795-002 | LOSARTAN POTASSIUM | HISUN PHARMACEUTICAL HANGZHOU CO LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2019/04/04 | N / N | DISCONTINUED | openFDA ↗ |
| A204795-003 | LOSARTAN POTASSIUM | HISUN PHARMACEUTICAL HANGZHOU CO LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2019/04/04 | N / N | DISCONTINUED | openFDA ↗ |
| A215959-001 | LOSARTAN POTASSIUM | GRANULES INDIA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2023/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215959-002 | LOSARTAN POTASSIUM | GRANULES INDIA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2023/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215959-003 | LOSARTAN POTASSIUM | GRANULES INDIA LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2023/02/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217396-001 | LOSARTAN POTASSIUM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2023/08/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217396-002 | LOSARTAN POTASSIUM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2023/08/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217396-003 | LOSARTAN POTASSIUM | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2023/08/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218551-001 | LOSARTAN POTASSIUM | APOTEX INC | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2024/06/04 | N / N | DISCONTINUED | openFDA ↗ |
| A218551-002 | LOSARTAN POTASSIUM | APOTEX INC | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2024/06/04 | N / N | DISCONTINUED | openFDA ↗ |
| A218551-003 | LOSARTAN POTASSIUM | APOTEX INC | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2024/06/04 | N / N | DISCONTINUED | openFDA ↗ |
| A219859-001 | LOSARTAN POTASSIUM | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 2025/09/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219859-002 | LOSARTAN POTASSIUM | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 2025/09/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219859-003 | LOSARTAN POTASSIUM | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 2025/09/19 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020386-001 | COZAAR | ORGANON LLC A SUB OF ORGANON AND CO | TABLET | ORAL | LOSARTAN POTASSIUM: 25MG | 1995/04/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020386-002 | COZAAR | ORGANON LLC A SUB OF ORGANON AND CO | TABLET | ORAL | LOSARTAN POTASSIUM: 50MG | 1995/04/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020386-003 | COZAAR | ORGANON LLC A SUB OF ORGANON AND CO | TABLET | ORAL | LOSARTAN POTASSIUM: 100MG | 1998/10/13 | Y / Y | HUMAN PRESCRIPTION DRUG | 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 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | 2023/01/10 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | 2023/01/10 | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H2022311150mg | 2022/03/08 | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20213818100mg | 2021/10/26 | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H2021381750mg | 2021/10/26 | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H20213250100mg | 2021/04/07 | Official source ↗ |
| Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized | 国药准字H20133120100mg | 2020/03/25 | Official source ↗ |
| Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized | 国药准字H2008037150mg | 2020/03/25 | Official source ↗ |
| Lek Pharmaceuticals d.d. | H2014091550mg | 2020/03/20 | Official source ↗ |
| Lek Pharmaceuticals d.d. | H2014091450mg | 2020/03/20 | Official source ↗ |
| Lek Pharmaceuticals d.d. | H2014091350mg | 2020/03/20 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | 2017/12/27 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | 2017/12/27 | Official source ↗ |
| Merck Sharp &Dohme Limited | H20160398; H20160401100mg | 2013/01/21 | Official source ↗ |
| Merck Sharp &Dohme Limited | H2016039750mg | 1997/06/23 | Official source ↗ |
NHSA approval numbers 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H2014301950mg | — | Official source ↗ |
| Beijing Shuang Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2013312350mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized | 国药准字H20133120100mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J20180006100mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H2021381750mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | — | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H20213250100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Beijing Shuang Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2013312350mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J20180006100mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H2021381750mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | — | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H20213250100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Beijing Shuang Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2013312350mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J20180006100mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H2021381750mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20143030100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2023303450mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Sichuan Hai Hui Pharma Co., Ltd. romanized | 国药准字H2008037150mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J2018005450mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20213818100mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ20171081100mg | — | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H2022311150mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Sichuan Hai Hui Pharma Co., Ltd. romanized | 国药准字H2008037150mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J2018005450mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20213818100mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ20171081100mg | — | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H2022311150mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Sichuan Hai Hui Pharma Co., Ltd. romanized | 国药准字H2008037150mg | — | Official source ↗ |
| Merck Sharp & Dohme Limited | 国药准字J2018005450mg | — | Official source ↗ |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20213818100mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ20171082100mg | — | Official source ↗ |
| Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized | 国药准字H2022311150mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H2007026450mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H2011004050mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20233035100mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ2017124550mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ2017124550mg | — | Official source ↗ |
| Organon Pharma(UK) Limited | 国药准字HJ2017124550mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2504306 | 2025/12/17 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2504305 | 2025/12/17 | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Jiangsu Fu Dan Fu Hua Pharma Co., Ltd. romanized | CYHS2601717 | 2026/07/17 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2602486 | 2026/10/10 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2602485 | 2026/10/10 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Jiangsu Fu Dan Fu Hua Pharma Co., Ltd. romanized | CYHS2601717 | 2026/07/17 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2602486 | 2026/10/10 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2602485 | 2026/10/10 | Official source ↗ |
API companies with A status 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20240001335 | 2026/04/29 | Official source ↗ |
| Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20210000982 | 2024/04/30 | Official source ↗ |
| Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20200000246 | 2026/04/27 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190009495 | 2025/03/27 | Official source ↗ |
| Hanmi Fine Chemical Co.,Ltd | Y20190009024 | — | Official source ↗ |
| Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190008907 | 2024/05/21 | Official source ↗ |
| Anhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanized | Y20190007246 | 2023/04/22 | Official source ↗ |
| Henan Kang Da Pharmaceutical Co., Ltd. romanized | Y20190007152 | — | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190006955 | 2023/03/24 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | Y20190006900 | — | Official source ↗ |
| Zhuo Zhou Dong Le Pharmaceutical Co., Ltd. romanized | Y20190006662 | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | Y20190006364 | 2025/02/06 | Official source ↗ |
| Yi Bin Hong Guang Pharmaceutical Factory romanized | Y20190006258 | — | Official source ↗ |
| Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | Y20190005761 | — | Official source ↗ |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | Y20190005042 | 2025/04/17 | Official source ↗ |
| Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Ying Chun Branch romanized | Y20190004222 | 2024/03/12 | Official source ↗ |
| Xu Chang Wei Lai Pharmaceutical Co., Ltd. romanized | Y20190002922 | 2026/02/26 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | Y20190001779 | 2024/09/26 | Official source ↗ |
| Shandong Duan Xin Tang Da Yu Pharma Co., Ltd. romanized | Y20190001472 | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190001465 | 2024/07/30 | 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 ↗ · 55-55 · 2022/09/13
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