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Matched- Active ingredients (original)
- ALLOPURINOL
- 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 applications26
RLD applicantCASPER PHARMA LLC
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 |
|---|---|---|---|---|---|---|---|---|---|
| A018659-001 | ALLOPURINOL | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1986/10/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A018659-002 | ALLOPURINOL | MYLAN PHARMACEUTICALS INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1986/10/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A070147-001 | ALLOPURINOL | PURACAP PHARMACEUTICAL LLC | TABLET | ORAL | ALLOPURINOL: 300MG | 1985/12/10 | N / N | DISCONTINUED | openFDA ↗ |
| A070150-001 | ALLOPURINOL | PURACAP PHARMACEUTICAL LLC | TABLET | ORAL | ALLOPURINOL: 100MG | 1985/12/10 | N / N | DISCONTINUED | openFDA ↗ |
| A070268-001 | ALLOPURINOL | AIPING PHARMACEUTICAL INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1985/12/31 | N / N | DISCONTINUED | openFDA ↗ |
| A070269-001 | ALLOPURINOL | SANDOZ INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1985/12/31 | N / N | DISCONTINUED | openFDA ↗ |
| A070466-001 | ALLOPURINOL | MUTUAL PHARMACEUTICAL CO INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1985/12/24 | N / N | DISCONTINUED | openFDA ↗ |
| A070467-001 | ALLOPURINOL | MUTUAL PHARMACEUTICAL CO INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1985/12/24 | N / N | DISCONTINUED | openFDA ↗ |
| A070579-001 | ALLOPURINOL | PUREPAC PHARMACEUTICAL CO | TABLET | ORAL | ALLOPURINOL: 100MG | 1986/04/14 | N / N | DISCONTINUED | openFDA ↗ |
| A070580-001 | ALLOPURINOL | PUREPAC PHARMACEUTICAL CO | TABLET | ORAL | ALLOPURINOL: 300MG | 1986/04/14 | N / N | DISCONTINUED | openFDA ↗ |
| A070950-001 | ALLOPURINOL | SUPERPHARM CORP | TABLET | ORAL | ALLOPURINOL: 100MG | 1988/11/30 | N / N | DISCONTINUED | openFDA ↗ |
| A070951-001 | ALLOPURINOL | SUPERPHARM CORP | TABLET | ORAL | ALLOPURINOL: 300MG | 1988/11/30 | N / N | DISCONTINUED | openFDA ↗ |
| A071450-001 | ALLOPURINOL | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1987/01/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071450-002 | ALLOPURINOL | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1987/01/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071587-001 | LOPURIN | DR REDDYS LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1987/04/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071587-002 | LOPURIN | DR REDDYS LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1987/04/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075798-001 | ALLOPURINOL | PH HEALTH LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2003/06/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075798-002 | ALLOPURINOL | PH HEALTH LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2003/06/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077353-001 | ALLOPURINOL | CHARTWELL LIFE MOLECULES LLC | TABLET | ORAL | ALLOPURINOL: 100MG | 2005/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077353-002 | ALLOPURINOL | CHARTWELL LIFE MOLECULES LLC | TABLET | ORAL | ALLOPURINOL: 300MG | 2005/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078253-001 | ALLOPURINOL | NORTHSTAR HEALTHCARE HOLDINGS LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2007/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A078253-002 | ALLOPURINOL | NORTHSTAR HEALTHCARE HOLDINGS LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2007/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A078390-001 | ALLOPURINOL | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 2007/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A078390-002 | ALLOPURINOL | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 2007/08/30 | N / N | DISCONTINUED | openFDA ↗ |
| A090637-001 | ALLOPURINOL | IPCA LABORATORIES LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2011/03/16 | N / N | DISCONTINUED | openFDA ↗ |
| A090637-002 | ALLOPURINOL | IPCA LABORATORIES LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2011/03/16 | N / N | DISCONTINUED | openFDA ↗ |
| A203154-001 | ALLOPURINOL | ACCORD HEALTHCARE INC | TABLET | ORAL | ALLOPURINOL: 100MG | 2013/05/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203154-002 | ALLOPURINOL | ACCORD HEALTHCARE INC | TABLET | ORAL | ALLOPURINOL: 300MG | 2013/05/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204467-001 | ALLOPURINOL | REGCON HOLDINGS LLC | TABLET | ORAL | ALLOPURINOL: 100MG | 2016/07/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204467-002 | ALLOPURINOL | REGCON HOLDINGS LLC | TABLET | ORAL | ALLOPURINOL: 300MG | 2016/07/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204467-003 | ALLOPURINOL | REGCON HOLDINGS LLC | TABLET | ORAL | ALLOPURINOL: 200MG | 2025/05/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210117-001 | ALLOPURINOL | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | ALLOPURINOL: 100MG | 2017/10/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210117-002 | ALLOPURINOL | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | ALLOPURINOL: 300MG | 2017/10/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210117-003 | ALLOPURINOL | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | ALLOPURINOL: 200MG | 2025/06/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211807-001 | ALLOPURINOL | LUPIN LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2023/12/14 | N / N | DISCONTINUED | openFDA ↗ |
| A211807-002 | ALLOPURINOL | LUPIN LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2023/12/14 | N / N | DISCONTINUED | openFDA ↗ |
| A211820-001 | ALLOPURINOL | UNICHEM LABORATORIES LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2019/03/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211820-002 | ALLOPURINOL | UNICHEM LABORATORIES LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2019/03/12 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214443-001 | ALLOPURINOL | HARMAN FINOCHEM LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2022/03/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214443-002 | ALLOPURINOL | HARMAN FINOCHEM LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2022/03/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214443-003 | ALLOPURINOL | HARMAN FINOCHEM LTD | TABLET | ORAL | ALLOPURINOL: 200MG | 2024/06/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215091-001 | ALLOPURINOL | AUROBINDO PHARMA LTD | TABLET | ORAL | ALLOPURINOL: 100MG | 2025/04/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215091-002 | ALLOPURINOL | AUROBINDO PHARMA LTD | TABLET | ORAL | ALLOPURINOL: 300MG | 2025/04/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217748-001 | ALLOPURINOL | HETERO LABS LTD UNIT V | TABLET | ORAL | ALLOPURINOL: 100MG | 2023/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217748-002 | ALLOPURINOL | HETERO LABS LTD UNIT V | TABLET | ORAL | ALLOPURINOL: 300MG | 2023/08/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N016084-001 | ZYLOPRIM | CASPER PHARMA LLC | TABLET | ORAL | ALLOPURINOL: 100MG | Approved before 1982 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N016084-002 | ZYLOPRIM | CASPER PHARMA LLC | TABLET | ORAL | ALLOPURINOL: 300MG | Approved before 1982 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N016084-003 | ZYLOPRIM | CASPER PHARMA LLC | TABLET | ORAL | ALLOPURINOL: 200MG | 2022/08/04 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018241-001 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1984/11/16 | N / N | DISCONTINUED | openFDA ↗ |
| N018241-002 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1984/11/16 | N / N | DISCONTINUED | openFDA ↗ |
| N018297-001 | LOPURIN | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | TABLET | ORAL | ALLOPURINOL: 100MG | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N018297-002 | LOPURIN | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | TABLET | ORAL | ALLOPURINOL: 300MG | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N018785-001 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1984/09/28 | N / N | DISCONTINUED | openFDA ↗ |
| N018785-002 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1984/09/28 | N / N | DISCONTINUED | openFDA ↗ |
| N018832-002 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 100MG | 1984/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018877-001 | ALLOPURINOL | WATSON LABORATORIES INC | TABLET | ORAL | ALLOPURINOL: 300MG | 1984/09/28 | N / N | 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 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | 2025/12/03 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202552090.1g | 2025/08/26 | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H440213680.1g | 2025/04/30 | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202446200.1g | 2024/08/05 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H202441320.1g | 2024/06/25 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H110207500.1g | 2022/01/18 | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310203340.1g | 2021/01/14 | Official source ↗ |
| Anhui Sheng Ying Pharma Co., Ltd. romanized | 国药准字H202653940.1g | 2026/07/28 | Official source ↗ |
NHSA approval numbers 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Shi Yan Jing Pharma Co., Ltd. romanized | 国药准字H110204320.1g | — | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H110207500.1g | — | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H440213680.1g | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H440214920.1g | — | Official source ↗ |
| Guangzhou Bai Sai Luo Pharma Co., Ltd. romanized | 国药准字H200231900.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310203340.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Yuan Da Sheng Ming Ke Xue (Jiangsu) Co., Ltd. romanized | 国药准字H320226590.1g | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H202441320.1g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H202552090.1g | — | Official source ↗ |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H330207710.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202446200.1g | — | Official source ↗ |
| Beijing Shi Yan Jing Pharma Co., Ltd. romanized | 国药准字H110204320.1g | — | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H110207500.1g | — | Official source ↗ |
| Guangdong Bi Di Pharma Co., Ltd. romanized | 国药准字H440213680.1g | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H440214920.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310203340.1g | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H500204550.1g | — | Official source ↗ |
| Chongqing Qing Yang Pharma Co., Ltd. romanized | 国药准字H500214220.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H202441320.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202446200.1g | — | Official source ↗ |
| Beijing Shi Yan Jing Pharma Co., Ltd. romanized | 国药准字H110204320.1g | — | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H110207500.1g | — | Official source ↗ |
| Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized | 国药准字H440214920.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310203340.1g | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H500204550.1g | — | Official source ↗ |
| Chongqing Qing Yang Pharma Co., Ltd. romanized | 国药准字H500214220.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202446200.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H310203340.1g | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H500204550.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H500204550.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | 国药准字H440216950.1g | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H500204550.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H350206610.1g | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202561090.1g | — | Official source ↗ |
| Feng Hua Biopharmaceutical (Jiangsu) Co., Ltd. romanized | 国药准字H200336830.1g | — | Official source ↗ |
| Chongqing Qing Yang Pharma Co., Ltd. romanized | 国药准字H500214220.1g | — | Official source ↗ |
| Hefei Jiu Lian Pharmaceutical Co., Ltd. romanized | 国药准字H340212480.1g | — | Official source ↗ |
| Chongqing Qing Yang Pharma Co., Ltd. romanized | 国药准字H500214220.1g | — | Official source ↗ |
| Hefei Jiu Lian Pharmaceutical Co., Ltd. romanized | 国药准字H340212480.1g | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2602495 | 2026/10/12 | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2602482 | 2026/10/10 | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2602481 | 2026/10/10 | Official source ↗ |
| Guangzhou Kang He Pharma Co., Ltd. romanized | CYHB2650124 | 2026/05/22 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2602495 | 2026/10/12 | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2602482 | 2026/10/10 | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2602481 | 2026/10/10 | Official source ↗ |
API companies with A status 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Pu Li Pharma Co., Ltd. romanized | Y20240000885 | 2026/01/26 | Official source ↗ |
| Hunan Ru Hong Pharmaceutical Co., Ltd. romanized | Y20240000695 | 2025/12/29 | Official source ↗ |
| Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20230001288 | 2025/11/12 | Official source ↗ |
| Anuh Pharma Ltd. | Y20230000298 | 2025/11/03 | Official source ↗ |
| Haleos Labs Limited | Y20230000857 | 2026/07/29 | Official source ↗ |
| Henan Dong Tai Pharmaceutical Co., Ltd. romanized | Y20230000920 | 2025/05/09 | Official source ↗ |
| EXEMED PHARMACEUTICALS | Y20220000456 | 2024/10/11 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20220001091 | 2024/05/21 | Official source ↗ |
| Hubei Guang Chen Pharma Co., Ltd. romanized | Y20210000683 | 2026/03/25 | Official source ↗ |
| INDOCO REMEDIES LTD | Y20200000216 | 2022/10/26 | Official source ↗ |
| Heilongjiang Mai Zhi Lun Pharmaceutical Co., Ltd. romanized | Y20190008802 | 2025/09/18 | Official source ↗ |
| Wuxi Zi Shan Pharma Co., Ltd. romanized | Y20190008282 | 2025/07/30 | Official source ↗ |
| Beijing Tai Yang Pharma Co., Ltd. romanized | Y20190008116 | 2025/04/23 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190008115 | — | Official source ↗ |
| Chongqing Qing Yang Pharma Co., Ltd. romanized | Y20190008082 | 2025/06/05 | Official source ↗ |
| Chongqing Xi Nan He Cheng Pharmaceutical Co., Ltd. romanized | Y20190007681 | — | Official source ↗ |
| Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20190000555 | 2026/08/17 | Official source ↗ |
| SICOR Società Italiana Corticosteroidi S.r.l. | Y20170002298 | 2025/05/25 | Official source ↗ |
| Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20170002275 | 2023/05/11 | 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 ↗ · 42-39 · 2021/06/28
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