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Sign in to subscribeDapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)
Matched- Active ingredients (original)
- DAPAGLIFLOZIN · METFORMIN HYDROCHLORIDE
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- 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 approval2014/10/29
ANDA applications10
RLD applicantASTRAZENECA AB
Currently marketed products: 37 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A211466-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MICRO LABS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211466-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MICRO LABS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211466-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MICRO LABS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211466-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MICRO LABS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211479-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211479-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211479-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211479-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MSN LABORATORIES PRIVATE LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211489-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211489-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211489-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211489-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211491-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211491-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211491-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211536-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CIPLA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211536-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CIPLA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211536-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CIPLA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| A211559-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211559-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211559-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211559-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211563-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ALKEM LABORATORIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211563-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ALKEM LABORATORIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211563-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ALKEM LABORATORIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211563-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | ALKEM LABORATORIES LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211579-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211579-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211579-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211579-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | LUPIN LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211583-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 2.5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211583-002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211583-003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211583-004 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211583-005 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211595-001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CIPLA LTD | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2026/04/06 | N / N | DISCONTINUED | openFDA ↗ |
| N205649-001 | XIGDUO XR | ASTRAZENECA AB | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 500MG | 2014/10/29 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205649-002 | XIGDUO XR | ASTRAZENECA AB | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 5MG METFORMIN HYDROCHLORIDE: 1GM | 2014/10/29 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205649-003 | XIGDUO XR | ASTRAZENECA AB | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 500MG | 2014/10/29 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205649-004 | XIGDUO XR | ASTRAZENECA AB | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 10MG METFORMIN HYDROCHLORIDE: 1GM | 2014/10/29 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205649-005 | XIGDUO XR | ASTRAZENECA AB | TABLET, EXTENDED RELEASE | ORAL | DAPAGLIFLOZIN: 2.5MG METFORMIN HYDROCHLORIDE: 1GM | 2017/07/28 | Y / 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 expiration2031/05/12This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2029/12/16
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 |
|---|---|---|---|---|---|---|
| N205649-001 | 6515117 | 2025/10/04 | Y / Y | U-493 | — | openFDA ↗ |
| N205649-001 | 6515117*PED | 2026/04/04 | — / — | — | — | openFDA ↗ |
| N205649-001 | 7919598 | 2029/12/16 | Y / — | — | — | openFDA ↗ |
| N205649-001 | 7919598*PED | 2030/06/16 | — / — | — | — | openFDA ↗ |
| N205649-001 | 8501698 | 2027/06/20 | — / Y | U-493 | — | openFDA ↗ |
| N205649-001 | 8501698*PED | 2027/12/20 | — / — | — | — | openFDA ↗ |
| N205649-001 | 8685934 | 2030/05/26 | — / — | U-1522 | — | openFDA ↗ |
| N205649-001 | 8685934*PED | 2030/11/26 | — / — | — | — | openFDA ↗ |
| N205649-001 | 9616028 | 2030/11/12 | — / Y | — | — | openFDA ↗ |
| N205649-001 | 9616028*PED | 2031/05/12 | — / — | — | — | openFDA ↗ |
| N205649-002 | 6515117 | 2025/10/04 | Y / Y | U-493 | — | openFDA ↗ |
| N205649-002 | 6515117*PED | 2026/04/04 | — / — | — | — | openFDA ↗ |
| N205649-002 | 7919598 | 2029/12/16 | Y / — | — | — | openFDA ↗ |
| N205649-002 | 7919598*PED | 2030/06/16 | — / — | — | — | openFDA ↗ |
| N205649-002 | 8501698 | 2027/06/20 | — / Y | U-493 | — | openFDA ↗ |
| N205649-002 | 8501698*PED | 2027/12/20 | — / — | — | — | openFDA ↗ |
| N205649-002 | 8685934 | 2030/05/26 | — / — | U-1522 | — | openFDA ↗ |
| N205649-002 | 8685934*PED | 2030/11/26 | — / — | — | — | openFDA ↗ |
| N205649-002 | 9616028 | 2030/11/12 | — / Y | — | — | openFDA ↗ |
| N205649-002 | 9616028*PED | 2031/05/12 | — / — | — | — | openFDA ↗ |
| N205649-003 | 6515117 | 2025/10/04 | Y / Y | U-493 | — | openFDA ↗ |
| N205649-003 | 6515117*PED | 2026/04/04 | — / — | — | — | openFDA ↗ |
| N205649-003 | 7919598 | 2029/12/16 | Y / — | — | — | openFDA ↗ |
| N205649-003 | 7919598*PED | 2030/06/16 | — / — | — | — | openFDA ↗ |
| N205649-003 | 8501698 | 2027/06/20 | — / Y | U-493 | — | openFDA ↗ |
| N205649-003 | 8501698*PED | 2027/12/20 | — / — | — | — | openFDA ↗ |
| N205649-003 | 8685934 | 2030/05/26 | — / — | U-1522 | — | openFDA ↗ |
| N205649-003 | 8685934*PED | 2030/11/26 | — / — | — | — | openFDA ↗ |
| N205649-003 | 9616028 | 2030/11/12 | — / Y | — | — | openFDA ↗ |
| N205649-003 | 9616028*PED | 2031/05/12 | — / — | — | — | openFDA ↗ |
| N205649-004 | 6515117 | 2025/10/04 | Y / Y | U-493 | — | openFDA ↗ |
| N205649-004 | 6515117*PED | 2026/04/04 | — / — | — | — | openFDA ↗ |
| N205649-004 | 7919598 | 2029/12/16 | Y / — | — | — | openFDA ↗ |
| N205649-004 | 7919598*PED | 2030/06/16 | — / — | — | — | openFDA ↗ |
| N205649-004 | 8501698 | 2027/06/20 | — / Y | U-493 | — | openFDA ↗ |
| N205649-004 | 8501698*PED | 2027/12/20 | — / — | — | — | openFDA ↗ |
| N205649-004 | 8685934 | 2030/05/26 | — / — | U-1522 | — | openFDA ↗ |
| N205649-004 | 8685934*PED | 2030/11/26 | — / — | — | — | openFDA ↗ |
| N205649-004 | 9616028 | 2030/11/12 | — / Y | — | — | openFDA ↗ |
| N205649-004 | 9616028*PED | 2031/05/12 | — / — | — | — | openFDA ↗ |
| N205649-005 | 6515117 | 2025/10/04 | Y / Y | U-493 | — | openFDA ↗ |
| N205649-005 | 6515117*PED | 2026/04/04 | — / — | — | — | openFDA ↗ |
| N205649-005 | 7919598 | 2029/12/16 | Y / — | — | — | openFDA ↗ |
| N205649-005 | 7919598*PED | 2030/06/16 | — / — | — | — | openFDA ↗ |
| N205649-005 | 8501698 | 2027/06/20 | — / Y | U-493 | — | openFDA ↗ |
| N205649-005 | 8501698*PED | 2027/12/20 | — / — | — | — | openFDA ↗ |
| N205649-005 | 8685934 | 2030/05/26 | — / — | U-1522 | — | openFDA ↗ |
| N205649-005 | 8685934*PED | 2030/11/26 | — / — | — | — | openFDA ↗ |
| N205649-005 | 9616028 | 2030/11/12 | — / Y | — | — | openFDA ↗ |
| N205649-005 | 9616028*PED | 2031/05/12 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2027/12/12
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| A211479-001 | PC | 2026/10/03 | openFDA ↗ |
| A211479-002 | PC | 2026/10/03 | openFDA ↗ |
| A211479-003 | PC | 2026/10/03 | openFDA ↗ |
| A211479-004 | PC | 2026/10/03 | openFDA ↗ |
| A211491-001 | PC | 2026/10/03 | openFDA ↗ |
| A211491-002 | PC | 2026/10/03 | openFDA ↗ |
| A211491-003 | PC | 2026/10/03 | openFDA ↗ |
| A211563-001 | PC | 2026/10/03 | openFDA ↗ |
| A211563-002 | PC | 2026/10/03 | openFDA ↗ |
| A211563-003 | PC | 2026/10/03 | openFDA ↗ |
| A211563-004 | PC | 2026/10/03 | openFDA ↗ |
| N205649-001 | NPP | 2027/06/12 | openFDA ↗ |
| N205649-001 | PED | 2027/12/12 | openFDA ↗ |
| N205649-002 | NPP | 2027/06/12 | openFDA ↗ |
| N205649-002 | PED | 2027/12/12 | openFDA ↗ |
| N205649-003 | NPP | 2027/06/12 | openFDA ↗ |
| N205649-003 | PED | 2027/12/12 | openFDA ↗ |
| N205649-004 | NPP | 2027/06/12 | openFDA ↗ |
| N205649-004 | PED | 2027/12/12 | openFDA ↗ |
| N205649-005 | NPP | 2027/06/12 | openFDA ↗ |
| N205649-005 | PED | 2027/12/12 | openFDA ↗ |
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 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20265610See source | 2026/08/04 | Official source ↗ |
| Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20265558See source | 2026/08/04 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20265176See source | 2026/07/14 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20264490See source | 2026/05/19 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | 2026/04/21 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20263923See source | 2026/04/14 | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | 2026/03/31 | Official source ↗ |
| Henan Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20263035See source | 2026/01/05 | Official source ↗ |
| Beijing Wei Lin Heng Chang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255287See source | 2025/09/02 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20254137See source | 2025/05/13 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20254138See source | 2025/05/13 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20253948See source | 2025/04/15 | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253855See source | 2025/04/08 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20253377See source | 2025/02/11 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253160See source | 2025/01/14 | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249466See source | 2024/12/01 | Official source ↗ |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244866See source | 2024/09/10 | Official source ↗ |
| Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | 国药准字H20256447See source | 2025/12/30 | Official source ↗ |
| Sichuan Mei Da Kang Pharma Co., Ltd. romanized | 国药准字H20266265See source | 2026/10/13 | Official source ↗ |
NHSA approval numbers 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| You Hui Pharma (Beijing) Co., Ltd. romanized | 国药准字H20255287See source | — | Official source ↗ |
| Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20265558See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253160See source | — | Official source ↗ |
| Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | 国药准字H20256447See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20254137See source | — | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253855See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253160See source | — | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253855See source | — | Official source ↗ |
| Nanjing Fang Sheng He Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253855See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20254138See source | — | Official source ↗ |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249466See source | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20265176See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20265610See source | — | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20263923See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263758See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264126See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20253948See source | — | Official source ↗ |
| AstraZeneca AB | 国药准字HJ20230077See source | — | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244866See source | — | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244866See source | — | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244866See source | — | Official source ↗ |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244866See source | — | Official source ↗ |
| AstraZeneca AB | 国药准字HJ20230080See source | — | Official source ↗ |
| AstraZeneca AB | 国药准字HJ20230080See source | — | Official source ↗ |
| AstraZeneca AB | 国药准字HJ20230080See source | — | Official source ↗ |
Under review 42
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized | CYHS2504241 | 2025/12/10 | Official source ↗ |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | CYHS2503344 | 2025/09/10 | Official source ↗ |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600907 | 2026/04/21 | Official source ↗ |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600904 | 2026/04/21 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600556 | 2026/02/27 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600555 | 2026/02/27 | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | CYHS2504057 | 2025/11/25 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | CYHS2600996 | 2026/04/28 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | CYHS2600993 | 2026/04/28 | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2502838 | 2025/08/06 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized | CYHB2601513 | 2026/08/10 | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | CYHS2600846 | 2026/04/13 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600072 | 2026/01/08 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600071 | 2026/01/08 | Official source ↗ |
| Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CYHS2600023 | 2026/01/05 | Official source ↗ |
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | CYHS2503405 | 2025/09/16 | Official source ↗ |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | CYHS2503603 | 2025/10/09 | Official source ↗ |
| Beijing Sai Er Bio Pharma Co., Ltd. romanized | CYHS2504130 | 2025/12/02 | Official source ↗ |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | CYHS2504022 | 2025/11/21 | Official source ↗ |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Pu Li Pharmaceutical Co., Ltd. romanized | CYHS2503192 | 2025/08/30 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2502842 | 2025/08/06 | Official source ↗ |
| Henan Li Nuo Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CYHS2502715 | 2025/07/28 | Official source ↗ |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | CYHS2502142 | 2025/06/16 | Official source ↗ |
| M/s Cipla Ltd.; Cipla (China) Pharmaceutical Co. Ltd | JYHS2500020 | 2025/04/25 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | CYHB2601998 | 2026/11/04 | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2602532 | 2026/10/14 | Official source ↗ |
| Shandong Ren He Pharmaceutical Co., Ltd. romanized | CYHS2602471 | 2026/10/10 | Official source ↗ |
| MSN Laboratories Private Limited | JYHS2600021 | 2026/09/23 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602366 | 2026/09/21 | Official source ↗ |
| Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Da Yang Pharmaceutical Co., Ltd. romanized | CYHS2601960 | 2026/08/11 | Official source ↗ |
| Shaanxi Xu Ang Bio Pharma Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | CYHS2601952 | 2026/08/10 | Official source ↗ |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2601046 | 2026/05/08 | Official source ↗ |
| Anhui Jia He Pharma Co., Ltd. romanized | CYHS2600977 | 2026/04/28 | Official source ↗ |
| Shanxi Bao Tai Pharma Co., Ltd. romanized | CYHS2600941 | 2026/04/24 | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600682 | 2026/03/19 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600554 | 2026/02/27 | Official source ↗ |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | CYHS2503836 | 2025/10/31 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2503104 | 2025/08/23 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2503103 | 2025/08/23 | Official source ↗ |
| Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2502907 | 2025/08/11 | Official source ↗ |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2502205 | 2025/06/19 | Official source ↗ |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2501602 | 2025/04/29 | Official source ↗ |
Generic-filing companies this year 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600907 | 2026/04/21 | Official source ↗ |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600904 | 2026/04/21 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600556 | 2026/02/27 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600555 | 2026/02/27 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | CYHS2600996 | 2026/04/28 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | CYHS2600993 | 2026/04/28 | Official source ↗ |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | CYHS2600846 | 2026/04/13 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600072 | 2026/01/08 | Official source ↗ |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600071 | 2026/01/08 | Official source ↗ |
| Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CYHS2600023 | 2026/01/05 | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2602532 | 2026/10/14 | Official source ↗ |
| Shandong Ren He Pharmaceutical Co., Ltd. romanized | CYHS2602471 | 2026/10/10 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2602366 | 2026/09/21 | Official source ↗ |
| Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Dong Cheng Da Yang Pharmaceutical Co., Ltd. romanized | CYHS2601960 | 2026/08/11 | Official source ↗ |
| Shaanxi Xu Ang Bio Pharma Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | CYHS2601952 | 2026/08/10 | Official source ↗ |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2601046 | 2026/05/08 | Official source ↗ |
| Anhui Jia He Pharma Co., Ltd. romanized | CYHS2600977 | 2026/04/28 | Official source ↗ |
| Shanxi Bao Tai Pharma Co., Ltd. romanized | CYHS2600941 | 2026/04/24 | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600682 | 2026/03/19 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600554 | 2026/02/27 | Official source ↗ |
API companies with A status 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- CDE chemical-drug catalogue detail ↗ · idCode=052fd479562d8c29c9b3a959c4cc83ae
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