Monthly
US$200
Billed every month
Sign in to subscribeBrexpiprazole Tablets
Matched- Active ingredients (original)
- BREXPIPRAZOLE
- 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 approval2015/07/10
ANDA applications12
RLD applicantOTSUKA PHARMACEUTICAL CO LTD
Currently marketed products: 12 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A213512-001 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213512-002 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213512-003 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213512-004 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213512-005 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213512-006 | BREXPIPRAZOLE | LUPIN LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/03/17 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-001 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-002 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-003 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-004 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-005 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213562-006 | BREXPIPRAZOLE | AMNEAL EU LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/01/31 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-001 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-002 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-003 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-004 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-005 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213570-006 | BREXPIPRAZOLE | SANDOZ INC | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2022/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-001 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-002 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-003 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-004 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-005 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213659-006 | BREXPIPRAZOLE | AUROBINDO PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/11/02 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-001 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-002 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-003 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-004 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-005 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213660-006 | BREXPIPRAZOLE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-001 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-002 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-003 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-004 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-005 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213669-006 | BREXPIPRAZOLE | HETERO LABS LTD UNIT V | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A213683-001 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213683-002 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213683-003 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213683-004 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213683-005 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213683-006 | BREXPIPRAZOLE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2025/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A213692-001 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213692-002 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213692-003 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213692-004 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213692-005 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213692-006 | BREXPIPRAZOLE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2022/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-001 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-002 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-003 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-004 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-005 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213718-006 | BREXPIPRAZOLE | AJANTA PHARMA LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/02/03 | N / N | DISCONTINUED | openFDA ↗ |
| A213731-001 | BREXPIPRAZOLE | APOTEX INC | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2025/02/24 | N / N | DISCONTINUED | openFDA ↗ |
| A213731-002 | BREXPIPRAZOLE | APOTEX INC | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2025/02/24 | N / N | DISCONTINUED | openFDA ↗ |
| A213731-003 | BREXPIPRAZOLE | APOTEX INC | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2025/02/24 | N / N | DISCONTINUED | openFDA ↗ |
| A213731-004 | BREXPIPRAZOLE | APOTEX INC | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2025/02/24 | N / N | DISCONTINUED | openFDA ↗ |
| A213731-005 | BREXPIPRAZOLE | APOTEX INC | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2025/02/24 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-001 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-002 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-003 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-004 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-005 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213758-006 | BREXPIPRAZOLE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-001 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-002 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-003 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-004 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-005 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| A213782-006 | BREXPIPRAZOLE | ALKEM LABORATORIES LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2023/11/28 | N / N | DISCONTINUED | openFDA ↗ |
| N205422-001 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.25MG | 2015/07/10 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205422-002 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 0.5MG | 2015/07/10 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205422-003 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 1MG | 2015/07/10 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205422-004 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 2MG | 2015/07/10 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205422-005 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 3MG | 2015/07/10 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N205422-006 | REXULTI | OTSUKA PHARMACEUTICAL CO LTD | TABLET | ORAL | BREXPIPRAZOLE: 4MG | 2015/07/10 | 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 expiration2033/04/12This latest date comes from a *PED row in the source and is displayed as listed.
Substance patent expiration (DS flag)2028/12/23
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 |
|---|---|---|---|---|---|---|
| N205422-001 | 10307419 | 2032/10/12 | — / Y | — | — | openFDA ↗ |
| N205422-001 | 10307419*PED | 2033/04/12 | — / — | — | — | openFDA ↗ |
| N205422-001 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-001 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-001 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-001 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-001 | 9839637 | 2026/04/12 | — / Y | U-543 | — | openFDA ↗ |
| N205422-001 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-001 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-001 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
| N205422-002 | 10307419 | 2032/10/12 | — / Y | — | — | openFDA ↗ |
| N205422-002 | 10307419*PED | 2033/04/12 | — / — | — | — | openFDA ↗ |
| N205422-002 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-002 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-002 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-002 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-002 | 9839637 | 2026/04/12 | — / Y | U-3281 | — | openFDA ↗ |
| N205422-002 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-002 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-002 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
| N205422-003 | 10307419 | 2032/10/12 | — / Y | — | — | openFDA ↗ |
| N205422-003 | 10307419*PED | 2033/04/12 | — / — | — | — | openFDA ↗ |
| N205422-003 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-003 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-003 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-003 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-003 | 9839637 | 2026/04/12 | — / Y | U-3281 | — | openFDA ↗ |
| N205422-003 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-003 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-003 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
| N205422-004 | 10307419 | 2032/10/12 | — / Y | — | — | openFDA ↗ |
| N205422-004 | 10307419*PED | 2033/04/12 | — / — | — | — | openFDA ↗ |
| N205422-004 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-004 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-004 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-004 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-004 | 9839637 | 2026/04/12 | — / Y | U-3281 | — | openFDA ↗ |
| N205422-004 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-004 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-004 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
| N205422-005 | 10307419 | 2032/10/12 | — / Y | — | — | openFDA ↗ |
| N205422-005 | 10307419*PED | 2033/04/12 | — / — | — | — | openFDA ↗ |
| N205422-005 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-005 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-005 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-005 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-005 | 9839637 | 2026/04/12 | — / Y | U-3281 | — | openFDA ↗ |
| N205422-005 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-005 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-005 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
| N205422-006 | 8349840 | 2026/04/12 | — / Y | U-1529 | — | openFDA ↗ |
| N205422-006 | 8349840*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-006 | 8618109 | 2026/04/12 | — / — | U-3281 | — | openFDA ↗ |
| N205422-006 | 8618109*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-006 | 9839637 | 2026/04/12 | — / Y | U-3281 | — | openFDA ↗ |
| N205422-006 | 9839637*PED | 2026/10/12 | — / — | — | — | openFDA ↗ |
| N205422-006 | RE48059 | 2028/12/23 | Y / — | — | — | openFDA ↗ |
| N205422-006 | RE48059*PED | 2029/06/23 | — / — | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: 2028/05/09
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N205422-001 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-001 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-001 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-001 | PED | 2026/11/10 | openFDA ↗ |
| N205422-002 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-002 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-002 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-002 | PED | 2026/11/10 | openFDA ↗ |
| N205422-003 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-003 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-003 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-003 | PED | 2026/11/10 | openFDA ↗ |
| N205422-004 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-004 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-004 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-004 | PED | 2026/11/10 | openFDA ↗ |
| N205422-005 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-005 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-005 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-005 | PED | 2026/11/10 | openFDA ↗ |
| N205422-006 | I-913 | 2026/05/10 | openFDA ↗ |
| N205422-006 | M-14 | 2027/05/08 | openFDA ↗ |
| N205422-006 | M-315 | 2028/05/09 | openFDA ↗ |
| N205422-006 | PED | 2026/11/10 | 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 26
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H202657702mg | 2026/08/25 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656841mg | 2026/08/18 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656832mg | 2026/08/18 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655421mg | 2026/08/04 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655412mg | 2026/08/04 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655430.25mg | 2026/08/04 | Official source ↗ |
| Beijing Ren Zhong Pharma Co., Ltd. romanized | 国药准字H202656172mg | 2026/08/04 | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655340.5mg | 2026/08/04 | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655362mg | 2026/08/04 | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655351mg | 2026/08/04 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653680.5mg | 2026/07/28 | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H202653962mg | 2026/07/28 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653671mg | 2026/07/28 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653662mg | 2026/07/28 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H202654020.5mg | 2026/07/28 | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653212mg | 2026/07/21 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H202652392mg | 2026/07/21 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H202652370.5mg | 2026/07/21 | Official source ↗ |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H202652381mg | 2026/07/21 | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653201mg | 2026/07/21 | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653181mg | 2026/07/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | 2026/07/21 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | 2026/07/21 | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653172mg | 2026/07/21 | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653190.5mg | 2026/07/21 | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653224mg | 2026/07/21 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650171mg | 2026/06/30 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650162mg | 2026/06/30 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650180.5mg | 2026/06/30 | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647501mg | 2026/06/10 | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647492mg | 2026/06/10 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645162mg | 2026/05/27 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645171mg | 2026/05/27 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645180.5mg | 2026/05/27 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642514mg | 2026/05/07 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642501mg | 2026/05/07 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642522mg | 2026/05/07 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642422mg | 2026/05/07 | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642411mg | 2026/05/07 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | 2026/04/14 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639772mg | 2026/04/14 | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639781mg | 2026/04/14 | Official source ↗ |
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638791mg | 2026/04/07 | Official source ↗ |
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638782mg | 2026/04/07 | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H202635982mg | 2026/03/17 | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H202635971mg | 2026/03/17 | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202635141mg | 2026/03/03 | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H202635132mg | 2026/03/03 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563891mg | 2025/12/22 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563882mg | 2025/12/22 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | 2025/12/16 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | 2025/12/16 | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563302mg | 2025/12/16 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H202562271mg | 2025/12/09 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H202562280.5mg | 2025/12/09 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561152mg | 2025/12/03 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561141mg | 2025/12/03 | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561164mg | 2025/12/03 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H202654002mg | 2026/07/28 | Official source ↗ |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H202654011mg | 2026/07/28 | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H202653951mg | 2026/07/28 | Official source ↗ |
NHSA approval numbers 56
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638782mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642522mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655340.5mg | — | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653201mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563882mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561141mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H202635971mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650162mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658932mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H202562271mg | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653680.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645180.5mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639781mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656841mg | — | Official source ↗ |
| Otsuka Pharmaceutical Co., Ltd. | 国药准字HJ202400501mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647492mg | — | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H202653951mg | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H202661812mg | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653181mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655430.25mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563302mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642411mg | — | Official source ↗ |
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638782mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655340.5mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563882mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658932mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639781mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656841mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647492mg | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653181mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563302mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642411mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655340.5mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563882mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658932mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656841mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647492mg | — | Official source ↗ |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H202653181mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202563302mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642411mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563882mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656841mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562722mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202639382mg | — | Official source ↗ |
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638791mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642514mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655351mg | — | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653224mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563891mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561152mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H202635982mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650171mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658941mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H202562280.5mg | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653671mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645171mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639772mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656832mg | — | Official source ↗ |
| Otsuka Pharmaceutical Co., Ltd. | 国药准字HJ202400512mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647501mg | — | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H202653962mg | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H202661821mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655421mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642422mg | — | Official source ↗ |
| Tianjin Drug Research Institute Pharma Co., Ltd. romanized | 国药准字H202638791mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655351mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563891mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658941mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H202639772mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656832mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647501mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642422mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655351mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563891mg | — | Official source ↗ |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H202658941mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H202656832mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H202647501mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H202642422mg | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H202563891mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H202562711mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652750.5mg | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H202642501mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655362mg | — | Official source ↗ |
| Jiangsu Fei Ma Pharma Co., Ltd. romanized | 国药准字H202653212mg | — | Official source ↗ |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H202561164mg | — | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H202650180.5mg | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H202653662mg | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H202645162mg | — | Official source ↗ |
| Hangzhou He Kang Pharma Co., Ltd. romanized | 国药准字H202661830.5mg | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H202655412mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655362mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H202655362mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H202652761mg | — | Official source ↗ |
Under review 31
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2504432 | 2025/12/26 | Official source ↗ |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2504431 | 2025/12/26 | Official source ↗ |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | CYHS2504430 | 2025/12/26 | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | CYHB2601890 | 2026/10/14 | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | CYHB2601889 | 2026/10/14 | Official source ↗ |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | CYHB2601888 | 2026/10/14 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601991 | 2026/08/13 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601990 | 2026/08/13 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601989 | 2026/08/13 | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | CYHS2601356 | 2026/06/10 | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | CYHS2601355 | 2026/06/10 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601160 | 2026/05/14 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601159 | 2026/05/14 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601158 | 2026/05/14 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600097 | 2026/01/08 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600096 | 2026/01/08 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600095 | 2026/01/08 | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | CYHS2600021 | 2026/01/05 | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | CYHS2504397 | 2025/12/25 | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | CYHS2504396 | 2025/12/25 | Official source ↗ |
| Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2503945 | 2025/11/13 | Official source ↗ |
| Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2503944 | 2025/11/13 | Official source ↗ |
| Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2503943 | 2025/11/13 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized | CYHS2503472 | 2025/09/19 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized | CYHS2503471 | 2025/09/19 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2503295 | 2025/09/05 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2503294 | 2025/09/05 | Official source ↗ |
| Ma Ying Long Pharma Group Co., Ltd. romanized | CYHS2503293 | 2025/09/05 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | CYHS2501710 | 2025/05/12 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | CYHS2501709 | 2025/05/12 | Official source ↗ |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | CYHS2501708 | 2025/05/12 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601991 | 2026/08/13 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601990 | 2026/08/13 | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | CYHS2601989 | 2026/08/13 | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | CYHS2601356 | 2026/06/10 | Official source ↗ |
| Zhejiang Hua Yi Pharmaceutical Co., Ltd. romanized | CYHS2601355 | 2026/06/10 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601160 | 2026/05/14 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601159 | 2026/05/14 | Official source ↗ |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601158 | 2026/05/14 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600097 | 2026/01/08 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600096 | 2026/01/08 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2600095 | 2026/01/08 | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | CYHS2600021 | 2026/01/05 | Official source ↗ |
API companies with A status 30
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000268 | 2026/08/13 | Official source ↗ |
| Jiangsu En Hua Pharma Co., Ltd. romanized | Y20250000258 | 2026/08/06 | Official source ↗ |
| Guangdong Xian Qiang Pharma Co., Ltd. romanized | Y20250000228 | 2026/07/28 | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | Y20250000127 | 2026/09/21 | Official source ↗ |
| Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20250000085 | 2026/06/01 | Official source ↗ |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20240001524 | 2026/07/04 | Official source ↗ |
| Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20240001562 | 2026/08/13 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20240001555 | 2026/08/24 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Y20240001517 | 2026/10/09 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240001445 | 2026/07/21 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | Y20240001452 | 2026/04/22 | Official source ↗ |
| Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20240001143 | 2026/07/13 | Official source ↗ |
| Tianjin Tai Pu Pharmaceutical Co., Ltd. romanized | Y20240000883 | 2025/12/29 | Official source ↗ |
| Liaoning Bei Feng Pharma Co., Ltd. romanized | Y20240000819 | 2026/03/06 | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240000877 | 2026/05/20 | Official source ↗ |
| Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20240000722 | 2026/09/13 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20240000766 | 2026/03/19 | Official source ↗ |
| Sichuan Hong Yuan Pharma Co., Ltd. romanized | Y20240000696 | 2026/08/11 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20240000533 | 2025/11/28 | Official source ↗ |
| Shandong Chen Long Pharma Co., Ltd. romanized | Y20240000693 | 2025/11/14 | Official source ↗ |
| Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20240000591 | 2025/12/14 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20240000436 | 2025/08/22 | Official source ↗ |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230001153 | 2026/03/06 | Official source ↗ |
| Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20230000743 | 2026/03/09 | Official source ↗ |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20230000669 | 2026/02/10 | Official source ↗ |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | Y20230000283 | 2026/06/16 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20220000975 | 2026/08/27 | Official source ↗ |
| Honour Lab Limited, Unit - III romanized | Y20210000838 | 2026/07/04 | Official source ↗ |
| Shandong Te Fa Man Pharma Co., Ltd. romanized | Y20210000803 | 2026/06/18 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Y20200001055 | 2026/05/18 | 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 ↗ · 55-72 · 2022/09/13
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy