| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND TRETINOIN | 216943 | 001 | ANDA | CLINDAMYCIN PHOSPHATE; TRETINOIN | GEL;TOPICAL | 1.2%;0.025% | No | No | 2023/09/01 | 2023/09/01 | ENCUBE | 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 |
| ISOTRETINOIN | 218194 | 003 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 25MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |
| ISOTRETINOIN | 218194 | 004 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |
| ISOTRETINOIN | 218194 | 005 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 35MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |
| ISOTRETINOIN | 218194 | 006 | ANDA | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No | 2024/01/29 | 2024/01/29 | AUROBINDO PHARMA | Prescription |
| TRETINOIN | 218561 | 001 | ANDA | TRETINOIN | CREAM;TOPICAL | 0.1% | No | No | 2024/04/25 | -- | ZYDUS LIFESCIENCES | Prescription |