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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NALBUPHINE HYDROCHLORIDE | 206506 | 001 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2019/02/06 | 2019/02/06 | RISING | Discontinued |
NALBUPHINE HYDROCHLORIDE | 206506 | 002 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No | 2019/02/06 | 2019/02/06 | RISING | Discontinued |
NALBUPHINE HYDROCHLORIDE | 216049 | 001 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2024/09/19 | 2024/09/19 | SOMERSET THERAPS LLC | Prescription |
NALBUPHINE HYDROCHLORIDE | 216049 | 002 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No | 2024/09/19 | 2024/09/19 | SOMERSET THERAPS LLC | Prescription |
NALBUPHINE HYDROCHLORIDE | 216050 | 001 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2024/09/19 | 2024/09/19 | SOMERSET THERAPS LLC | Prescription |
NALBUPHINE HYDROCHLORIDE | 216050 | 002 | ANDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No | 2024/09/19 | 2024/09/19 | SOMERSET THERAPS LLC | Prescription |