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Matched- Active ingredients (original)
- ACARBOSE
- 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 approval1995/09/06
ANDA applications8
RLD applicantBAYER HEALTHCARE PHARMACEUTICALS INC
Currently marketed products: 15 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A077532-001 | ACARBOSE | WATSON LABORATORIES INC | TABLET | ORAL | ACARBOSE: 25MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077532-002 | ACARBOSE | WATSON LABORATORIES INC | TABLET | ORAL | ACARBOSE: 50MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077532-003 | ACARBOSE | WATSON LABORATORIES INC | TABLET | ORAL | ACARBOSE: 100MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078441-001 | ACARBOSE | IMPAX LABORATORIES INC | TABLET | ORAL | ACARBOSE: 25MG | 2009/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078441-002 | ACARBOSE | IMPAX LABORATORIES INC | TABLET | ORAL | ACARBOSE: 50MG | 2009/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078441-003 | ACARBOSE | IMPAX LABORATORIES INC | TABLET | ORAL | ACARBOSE: 100MG | 2009/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078470-001 | ACARBOSE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ACARBOSE: 25MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078470-002 | ACARBOSE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ACARBOSE: 50MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078470-003 | ACARBOSE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ACARBOSE: 100MG | 2008/05/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090912-001 | ACARBOSE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | ACARBOSE: 25MG | 2011/07/27 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090912-002 | ACARBOSE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | ACARBOSE: 50MG | 2011/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090912-003 | ACARBOSE | STRIDES PHARMA GLOBAL PTE LTD | TABLET | ORAL | ACARBOSE: 100MG | 2011/07/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091053-001 | ACARBOSE | NATCO PHARMA USA LLC | TABLET | ORAL | ACARBOSE: 25MG | 2011/01/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091053-002 | ACARBOSE | NATCO PHARMA USA LLC | TABLET | ORAL | ACARBOSE: 50MG | 2011/01/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091053-003 | ACARBOSE | NATCO PHARMA USA LLC | TABLET | ORAL | ACARBOSE: 100MG | 2011/01/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091343-001 | ACARBOSE | SOMERSET THERAPEUTICS LLC | TABLET | ORAL | ACARBOSE: 25MG | 2013/10/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091343-002 | ACARBOSE | SOMERSET THERAPEUTICS LLC | TABLET | ORAL | ACARBOSE: 50MG | 2013/10/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091343-003 | ACARBOSE | SOMERSET THERAPEUTICS LLC | TABLET | ORAL | ACARBOSE: 100MG | 2013/10/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202271-001 | ACARBOSE | AVET LIFESCIENCES LTD | TABLET | ORAL | ACARBOSE: 25MG | 2012/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A202271-002 | ACARBOSE | AVET LIFESCIENCES LTD | TABLET | ORAL | ACARBOSE: 50MG | 2012/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A202271-003 | ACARBOSE | AVET LIFESCIENCES LTD | TABLET | ORAL | ACARBOSE: 100MG | 2012/02/07 | N / N | DISCONTINUED | openFDA ↗ |
| A213821-001 | ACARBOSE | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | TABLET | ORAL | ACARBOSE: 25MG | 2020/08/18 | N / N | DISCONTINUED | openFDA ↗ |
| A213821-002 | ACARBOSE | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | TABLET | ORAL | ACARBOSE: 50MG | 2020/08/18 | N / N | DISCONTINUED | openFDA ↗ |
| A213821-003 | ACARBOSE | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | TABLET | ORAL | ACARBOSE: 100MG | 2020/08/18 | N / N | DISCONTINUED | openFDA ↗ |
| N020482-001 | PRECOSE | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | ACARBOSE: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1995/09/06 | Y / N | DISCONTINUED | openFDA ↗ |
| N020482-002 | PRECOSE | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | ACARBOSE: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1995/09/06 | Y / N | DISCONTINUED | openFDA ↗ |
| N020482-004 | PRECOSE | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | ACARBOSE: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1997/05/29 | 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 24
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H202652680.1g | 2026/07/21 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H2026526750mg | 2026/07/21 | Official source ↗ |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H2025619050mg | 2025/12/09 | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | 2025/08/26 | Official source ↗ |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H2025346350mg | 2025/02/25 | Official source ↗ |
| Sheng Da Chemical Pharmaceutical Co., Ltd. romanized | 国药准字HC2024000750mg | 2024/10/16 | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H2024451550mg | 2024/07/30 | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20244564100mg | 2024/07/30 | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | 2024/07/30 | Official source ↗ |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2024387650mg | 2024/06/04 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202370400.1g | 2023/04/18 | Official source ↗ |
| Guizhou Tian An Pharma Co., Ltd. romanized | 国药准字H2022365250mg | 2022/09/14 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | 2022/03/16 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20223135100mg | 2022/03/16 | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2022314150mg | 2022/03/16 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20227010100mg | 2022/01/30 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | 2022/01/30 | Official source ↗ |
| Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2021394850mg | 2021/12/14 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2021387650mg | 2021/11/17 | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | 2021/08/25 | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | 2021/08/25 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | 国药准字H2021322250mg | 2021/03/30 | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | 2021/01/19 | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H2020356250mg | 2020/11/10 | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H20203563100mg | 2020/11/10 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2020331150mg | 2020/07/16 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | 2020/07/16 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | 2019/12/06 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | 2019/05/27 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | 2018/11/19 | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H200107160.1g | 2001/11/05 | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H1999020550mg | 1999/09/03 | Official source ↗ |
| Bayer Vital GmbH | H2013090650mg | 1994/12/09 | Official source ↗ |
| Bayer Vital GmbH | H20130907100mg | 1994/12/09 | Official source ↗ |
NHSA approval numbers 30
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H200107160.1g | — | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H20203563100mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2022314150mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2024387650mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H2024451550mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2020331150mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2021394850mg | — | Official source ↗ |
| Shuang He Tian An Pharma (Guizhou) Co., Ltd. romanized | 国药准字H2022365250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H2021322250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2021387650mg | — | Official source ↗ |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H2025346350mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H200107160.1g | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2022314150mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2021394850mg | — | Official source ↗ |
| Shuang He Tian An Pharma (Guizhou) Co., Ltd. romanized | 国药准字H2022365250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H2021322250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2021387650mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H2025346350mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2022314150mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2021394850mg | — | Official source ↗ |
| Shuang He Tian An Pharma (Guizhou) Co., Ltd. romanized | 国药准字H2022365250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H2021322250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H2021387650mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H2025346350mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Hua Run Sai Ke Pharma Co., Ltd. romanized | 国药准字H2022314150mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Shuang He Tian An Pharma (Guizhou) Co., Ltd. romanized | 国药准字H2022365250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H2021322250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Le Pu Pharmaceutical Technology Co., Ltd. romanized | 国药准字H2021322250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H2022313450mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H2022306250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H2025525450mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2019336050mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H2020331450mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H2024456350mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H2021303250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H2025619050mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H2021366150mg | — | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H1999020550mg | — | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H2020356250mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20223135100mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2020331150mg | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20244564100mg | — | Official source ↗ |
| Guizhou Sheng Ji Tang Pharmaceutical Co., Ltd. romanized | 国药准字H2021394850mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202370400.1g | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H1999020550mg | — | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H2020356250mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H2020331150mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202370400.1g | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H1999020550mg | — | Official source ↗ |
| Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized | 国药准字H2020356250mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H202370400.1g | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H2002020250mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 国药准字H20213662100mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20153002100mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20227010100mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20227010100mg | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20227010100mg | — | Official source ↗ |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H2023387050mg | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2601716 | 2026/07/17 | Official source ↗ |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2601715 | 2026/07/17 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | CYHS2602591 | 2026/10/22 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2601716 | 2026/07/17 | Official source ↗ |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2601715 | 2026/07/17 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | CYHS2602591 | 2026/10/22 | Official source ↗ |
API companies with A status 14
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yu Xing Bio (Group) Co., Ltd. romanized | Y20240000315 | 2026/09/01 | Official source ↗ |
| Xin Yu Pharma Co., Ltd. romanized | Y20220000593 | 2026/07/21 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Y20220000409 | 2026/05/20 | Official source ↗ |
| Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized | Y20220000197 | 2024/01/17 | Official source ↗ |
| Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20210000915 | 2023/02/03 | Official source ↗ |
| Li Zhu Group Fuzhou Fu Xing Pharmaceuticals Co., Ltd. romanized | Y20210000114 | 2022/12/29 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | Y20200001403 | 2026/10/23 | Official source ↗ |
| Bayer Pharma AG | Y20190009956 | — | Official source ↗ |
| CKD Bio Corporation | Y20190009952 | 2023/07/27 | Official source ↗ |
| CKD Bio Corporation | Y20190009951 | 2025/02/19 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20190009480 | — | Official source ↗ |
| Shi Yao Group Sheng Xue Pu Tao Tang Co., Ltd. romanized | Y20190009389 | 2024/07/20 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190008441 | 2024/08/02 | Official source ↗ |
| Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized | Y20190006488 | 2026/06/17 | Official source ↗ |
| CKD Bio Corporation | Y20190000184 | 2024/10/08 | Official source ↗ |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20170001909 | 2022/11/15 | Official source ↗ |
| Bayer AG | Y20170001896 | 2025/09/28 | 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 ↗ · 36-55 · 2021/01/25
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