| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DIAZEPAM | 077749 | 003 | ANDA | DIAZEPAM | TABLET;ORAL | 10MG | No | No | 2006/03/31 | 2006/03/31 | STRIDES PHARMA INTL | Discontinued |
| DIAZEPAM | 204433 | 001 | ANDA | DIAZEPAM | CONCENTRATE;ORAL | 5MG/ML | No | No | 2014/04/14 | 2014/04/14 | CHARTWELL MOLECULAR | Prescription |
| DIAZEPAM | 206477 | 001 | ANDA | DIAZEPAM | SOLUTION;ORAL | 5MG/5ML | No | No | 2016/06/24 | 2016/06/24 | CHARTWELL MOLECULAR | Prescription |
| DIAZEPAM | 210363 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | Yes | 2019/03/18 | 2019/03/18 | REGCON HOLDINGS | Prescription |
| DIAZEPAM | 211998 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 50MG/10ML (5MG/ML) | No | No | 2019/12/26 | 2019/12/26 | REGCON HOLDINGS | Prescription |
| DIAZEPAM | 214745 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No | 2022/11/10 | 2022/11/10 | FRESENIUS KABI USA | Prescription |
| DIAZEPAM | 091076 | 001 | ANDA | DIAZEPAM | GEL;RECTAL | 10MG/2ML (5MG/ML) | No | No | 2023/05/30 | 2023/05/30 | NOVEL LABS INC | Prescription |
| DIAZEPAM | 091076 | 002 | ANDA | DIAZEPAM | GEL;RECTAL | 20MG/4ML (5MG/ML) | No | No | 2023/05/30 | 2023/05/30 | NOVEL LABS INC | Prescription |
| DIAZEPAM | 217843 | 001 | ANDA | DIAZEPAM | TABLET;ORAL | 2MG | No | No | 2023/12/14 | 2023/12/14 | AUROBINDO PHARMA LTD | Prescription |
| DIAZEPAM | 217843 | 002 | ANDA | DIAZEPAM | TABLET;ORAL | 5MG | No | No | 2023/12/14 | 2023/12/14 | AUROBINDO PHARMA LTD | Prescription |
| DIAZEPAM | 217843 | 003 | ANDA | DIAZEPAM | TABLET;ORAL | 10MG | No | No | 2023/12/14 | 2023/12/14 | AUROBINDO PHARMA LTD | Prescription |
| DIAZEPAM | 218450 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No | 2024/04/25 | 2024/04/25 | ALEMBIC | Prescription |
| DIAZEPAM | 218422 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No | 2024/07/18 | 2024/07/18 | DR REDDYS | Prescription |
| DIAZEPAM | 217178 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 10MG/2ML (5MG/ML) | No | No | 2024/12/31 | 2024/12/31 | LONG GROVE PHARMS | Prescription |
| DIAZEPAM | 216422 | 001 | ANDA | DIAZEPAM | INJECTABLE;INJECTION | 50MG/10ML (5MG/ML) | No | No | 2025/05/19 | 2025/05/19 | GALENICUM HLTH | Prescription |
| DIAZEPAM | 219320 | 005 | ANDA | DIAZEPAM | Spray | 10MG/1SPRAY | No | No | 2025/11/12 (TA) | -- | PADAGIS ISRAEL PHARMA LTD | None (Tentative Approval) |
| DIAZEPAM | 217468 | 001 | ANDA | DIAZEPAM | GEL;RECTAL | 2.5MG/0.5ML (5MG/ML) | No | No | 2025/11/14 | 2025/11/14 | NAVINTA LLC | Prescription |
| DIAZEPAM | 217468 | 002 | ANDA | DIAZEPAM | GEL;RECTAL | 10MG/2ML (5MG/ML) | No | No | 2025/11/14 | 2025/11/14 | NAVINTA LLC | Prescription |
| DIAZEPAM | 217468 | 003 | ANDA | DIAZEPAM | GEL;RECTAL | 20MG/4ML (5MG/ML) | No | No | 2025/11/14 | 2025/11/14 | NAVINTA LLC | Prescription |