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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | 204797 | 001 | ANDA | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No | 2021/04/15 | 2021/04/15 | EXELA PHARMA | Discontinued |
ACETYLCYSTEINE | 213693 | 001 | ANDA | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No | 2022/02/03 | 2022/02/03 | GLENMARK PHARMS INC | Prescription |
ACETYLCYSTEINE | 215620 | 001 | ANDA | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No | 2022/02/23 | 2022/02/23 | INDOCO | Prescription |
ACETYLCYSTEINE | 217182 | 001 | ANDA | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No | 2023/04/19 | 2023/04/19 | STERISCIENCE SPECLTS | Prescription |
ACETYLCYSTEINE | 205643 | 001 | ANDA | ACETYLCYSTEINE | SOLUTION;INHALATION, ORAL | 20% | No | No | 2023/11/01 | 2023/11/01 | EXELA PHARMA | Discontinued |
ACETYLCYSTEINE | 218397 | 001 | ANDA | ACETYLCYSTEINE | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | No | No | 2024/06/07 | 2024/06/07 | SOMERSET THERAPS LLC | Prescription |