| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | 209047 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2017/06/07 | 2017/06/07 | STRIDES PHARMA | Prescription |
| AMANTADINE HYDROCHLORIDE | 209035 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2017/06/09 | 2017/06/09 | STRIDES PHARMA | Prescription |
| AMANTADINE HYDROCHLORIDE | 209171 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2017/06/12 | 2017/06/12 | HERITAGE PHARMA | Prescription |
| AMANTADINE HYDROCHLORIDE | 209221 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2017/06/15 | 2017/06/15 | CHARTWELL MOLECULAR | Discontinued |
| AMANTADINE HYDROCHLORIDE | 208966 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2017/06/21 | 2017/06/21 | ALEMBIC | Prescription |
| AMANTADINE HYDROCHLORIDE | 210403 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2018/02/07 | 2018/02/07 | JUBILANT GENERICS | Discontinued |
| AMANTADINE HYDROCHLORIDE | 210129 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2020/03/02 | 2020/03/02 | RISING | Prescription |
| AMANTADINE HYDROCHLORIDE | 210215 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2020/03/10 | 2020/03/10 | ATHEM | Prescription |
| AMANTADINE HYDROCHLORIDE | 212044 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2020/05/21 | 2020/05/21 | RUBICON | Prescription |
| AMANTADINE HYDROCHLORIDE | 214284 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2020/10/15 | 2020/10/15 | ALEMBIC | Prescription |
| AMANTADINE HYDROCHLORIDE | 214178 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | SYRUP;ORAL | 50MG/5ML | No | No | 2021/08/20 | 2021/08/20 | ELYSIUM | Prescription |
| AMANTADINE HYDROCHLORIDE | 211354 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2022/02/18 | 2022/02/18 | STRIDES PHARMA | Prescription |
| AMANTADINE HYDROCHLORIDE | 212407 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2022/05/27 | 2022/05/27 | EDENBRIDGE PHARMS | Discontinued |
| AMANTADINE | 214897 | 001 | ANDA | AMANTADINE | CAPSULE, EXTENDED RELEASE;ORAL | 65.5MG | No | No | 2022/09/29 (TA) | -- | ZYDUS PHARMS USA INC | None (Tentative Approval) |
| AMANTADINE | 214897 | 002 | ANDA | AMANTADINE | CAPSULE, EXTENDED RELEASE;ORAL | 137MG | No | No | 2022/09/29 (TA) | -- | ZYDUS PHARMS USA INC | None (Tentative Approval) |
| AMANTADINE HYDROCHLORIDE | 214580 | 001 | ANDA | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | No | No | 2022/12/20 | 2022/12/20 | HUMANWELL PURACAP | Prescription |