| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OBETICHOLIC ACID | 214862 | 001 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 5MG | No | No | 2023/05/30 | 2023/05/30 | APOTEX | Discontinued |
| OBETICHOLIC ACID | 214862 | 002 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 10MG | No | No | 2023/05/30 | 2023/05/30 | APOTEX | Discontinued |
| OBETICHOLIC ACID | 214980 | 001 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 5MG | No | No | 2023/05/30 | 2023/05/30 | LUPIN LTD | Discontinued |
| OBETICHOLIC ACID | 214980 | 002 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 10MG | No | No | 2023/05/30 | 2023/05/30 | LUPIN LTD | Discontinued |
| OBETICHOLIC ACID | 215017 | 001 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 5MG | No | No | 2023/05/30 | 2023/05/30 | MSN | Discontinued |
| OBETICHOLIC ACID | 215017 | 002 | ANDA | OBETICHOLIC ACID | TABLET;ORAL | 10MG | No | No | 2023/05/30 | 2023/05/30 | MSN | Discontinued |
| OBETICHOLIC ACID | 214935 | 002 | ANDA | OBETICHOLIC ACID | TABLET; ORAL | 10mg | No | No | 2023/07/20 (TA) | -- | OPTIMUS PHARMA PRIVATE LTD | None (Tentative Approval) |