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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
BRETHINE | 017849 | 001 | NDA | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | Yes | No | 1976/05/17 | Approved Prior to Jan 1, 1982 | ANI PHARMS | Prescription |
BRETHINE | 017849 | 002 | NDA | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | Yes | No | 1976/05/17 | Approved Prior to Jan 1, 1982 | ANI PHARMS | Prescription |
BRETHINE | 018571 | 001 | NDA | TERBUTALINE SULFATE | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1981/11/30 | Approved Prior to Jan 1, 1982 | PHARMACARE | Discontinued |