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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
E.E.S. 400 | 061639 | 002 | ANDA | ERYTHROMYCIN ETHYLSUCCINATE | SUSPENSION;ORAL | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1973/10/15 | Approved Prior to Jan 1, 1982 | ARBOR PHARMS LLC | Discontinued |
E.E.S. 400 | 061905 | 001 | ANDA | ERYTHROMYCIN ETHYLSUCCINATE | TABLET;ORAL | EQ 400MG BASE | No | No | 1982/08/12 | Approved Prior to Jan 1, 1982 | CARNEGIE | Discontinued |
E.E.S. 400 | 061905 | 002 | ANDA | ERYTHROMYCIN ETHYLSUCCINATE | TABLET;ORAL | EQ 400MG BASE | No | Yes | 1982/08/12 | 1982/08/12 | CARNEGIE | Prescription |