| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TERRAMYCIN W/ POLYMYXIN | 061841 | 001 | ANDA | OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | OINTMENT;OTIC | EQ 5MG BASE/GM;10,000 UNITS/GM | No | No | -- | Approved Prior to Jan 1, 1982 | PFIZER | Discontinued |
| TERRAMYCIN W/ POLYMYXIN B SULFATE | 061015 | 001 | NDA | OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE | OINTMENT;OPHTHALMIC | EQ 5MG BASE/GM;10,000 UNITS/GM | No | No | 1965/07/08 | Approved Prior to Jan 1, 1982 | CASPER PHARMA LLC | Discontinued |