| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PROTAMINE SULFATE | 007413 | 001 | NDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No | -- | Approved Prior to Jan 1, 1982 | PHARMACIA AND UPJOHN | Discontinued |
| PROTAMINE SULFATE | 007413 | 002 | NDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 250MG/VIAL | No | No | -- | 1984/08/02 | PHARMACIA AND UPJOHN | Discontinued |
| PROTAMINE SULFATE | 089306 | 001 | ANDA | PROTAMINE SULFATE | Injectable; Injection | 10MG/ML | No | No | -- | -- | QUAD PHARMS | Discontinued |
| PROTAMINE SULFATE | 089307 | 001 | ANDA | PROTAMINE SULFATE | Injectable; Injection | 50MG/VIAL | No | No | -- | -- | QUAD PHARMS | Discontinued |
| PROTAMINE SULFATE | 006460 | 002 | NDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1969/08/13 | Approved Prior to Jan 1, 1982 | LILLY | Discontinued |
| PROTAMINE SULFATE | 089474 | 001 | ANDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 10MG/ML | No | No | 1986/11/05 | 1986/11/05 | HIKMA | Discontinued |
| PROTAMINE SULFATE | 089475 | 001 | ANDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 10MG/ML | No | No | 1986/11/05 | 1986/11/05 | HIKMA | Discontinued |
| PROTAMINE SULFATE | 089454 | 001 | ANDA | PROTAMINE SULFATE | INJECTABLE;INJECTION | 10MG/ML | No | Yes | 1987/04/07 | 1987/04/07 | FRESENIUS KABI USA | Prescription |