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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
POLYSPORIN | 050167 | 002 | NDA | BACITRACIN ZINC; POLYMYXIN B SULFATE | AEROSOL;TOPICAL | 10,000 UNITS/GM;2,000,000 UNITS/GM | No | No | -- | 1985/03/01 | GLAXOSMITHKLINE | Discontinued |
POLYSPORIN | 061229 | 001 | ANDA | BACITRACIN ZINC; POLYMYXIN B SULFATE | OINTMENT;OPHTHALMIC | 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** | No | No | 1974/04/16 | Approved Prior to Jan 1, 1982 | MONARCH PHARMS | Discontinued |