| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ISOTRETINOIN | 207792 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No | 2017/09/29 | 2017/09/29 | AMNEAL PHARMS NY | Prescription |
| ISOTRETINOIN | 207792 | 002 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No | 2017/09/29 | 2017/09/29 | AMNEAL PHARMS NY | Prescription |
| ISOTRETINOIN | 207792 | 003 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No | 2017/09/29 | 2017/09/29 | AMNEAL PHARMS NY | Prescription |
| ISOTRETINOIN | 207792 | 004 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No | 2017/09/29 | 2017/09/29 | AMNEAL PHARMS NY | Prescription |
| ISOTRETINOIN | 205063 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 205063 | 002 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 205063 | 003 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 25MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 205063 | 004 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 205063 | 005 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 35MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 205063 | 006 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No | 2021/03/31 | 2021/03/31 | ACTAVIS LABS FL | Prescription |
| ISOTRETINOIN | 213571 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No | 2021/04/12 | 2021/04/12 | UPSHER SMITH LABS | Prescription |
| ISOTRETINOIN | 212333 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No | 2021/09/21 | 2021/09/21 | UPSHER SMITH LABS | Prescription |
| ISOTRETINOIN | 212333 | 002 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No | 2021/09/21 | 2021/09/21 | UPSHER SMITH LABS | Prescription |
| ISOTRETINOIN | 212333 | 003 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No | 2021/09/21 | 2021/09/21 | UPSHER SMITH LABS | Prescription |
| ISOTRETINOIN | 211568 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No | 2023/08/29 | 2023/08/29 | ZYDUS PHARMS | Prescription |
| ISOTRETINOIN | 211568 | 002 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No | 2023/08/29 | 2023/08/29 | ZYDUS PHARMS | Prescription |
| ISOTRETINOIN | 211568 | 003 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No | 2023/08/29 | 2023/08/29 | ZYDUS PHARMS | Prescription |
| ISOTRETINOIN | 211568 | 004 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No | 2023/08/29 | 2023/08/29 | ZYDUS PHARMS | Prescription |
| ISOTRETINOIN | 218194 | 001 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |
| ISOTRETINOIN | 218194 | 002 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |