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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
FENTANYL CITRATE | 206329 | 004 | ANDA | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE | No | No | 2022/08/22 | 2022/08/22 | DR REDDYS LABS SA | Discontinued |
FENTANYL CITRATE | 206329 | 005 | ANDA | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE | No | No | 2022/08/22 | 2022/08/22 | DR REDDYS LABS SA | Discontinued |
FENTANYL CITRATE | 206329 | 006 | ANDA | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE | No | No | 2022/08/22 | 2022/08/22 | DR REDDYS LABS SA | Discontinued |
FENTANYL CITRATE | 215870 | 001 | NDA | FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | Yes | No | 2023/02/08 | 2023/02/08 | EXELA PHARMA | Discontinued |
FENTANYL CITRATE | 215870 | 002 | NDA | FENTANYL CITRATE | SOLUTION;INTRAVENOUS | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | Yes | No | 2023/02/08 | 2023/02/08 | EXELA PHARMA | Discontinued |