| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SUGAMMADEX SODIUM | 215701 | 001 | ANDA | SUGAMMADEX SODIUM | INJECTABLE;INJECTION | 200MG/2ML(100MG/ML) | No | No | 2023/03/20 (TA) | -- | SHANDONG | None (Tentative Approval) |
| SUGAMMADEX SODIUM | 215701 | 002 | ANDA | SUGAMMADEX SODIUM | INJECTABLE;INJECTION | 500MG/5ML(100MG/ML) | No | No | 2023/03/20 (TA) | -- | SHANDONG | None (Tentative Approval) |
| SUGAMMADEX SODIUM | 214337 | 001 | ANDA | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | No | No | 2023/06/09 | 2023/06/09 | ASPIRO | Prescription |
| SUGAMMADEX SODIUM | 214337 | 002 | ANDA | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | No | No | 2023/06/09 | 2023/06/09 | ASPIRO | Prescription |
| SUGAMMADEX SODIUM | 214290 | 001 | ANDA | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | No | No | 2023/10/04 | 2023/10/04 | ZYDUS PHARMS | Discontinued |
| SUGAMMADEX SODIUM | 214290 | 002 | ANDA | SUGAMMADEX SODIUM | SOLUTION;INTRAVENOUS | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | No | No | 2023/10/04 | 2023/10/04 | ZYDUS PHARMS | Discontinued |