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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TAGAMET HB | 020238 | 001 | NDA | CIMETIDINE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/06/19 | 1995/06/19 | MEDTECH PRODUCTS | Discontinued |
TAGAMET HB | 020238 | 002 | NDA | CIMETIDINE | TABLET;ORAL | 200MG | Yes | Yes | 1995/06/19 | 1996/08/21 | MEDTECH PRODUCTS | Over-the-counter |
TAGAMET HB 200 | 020951 | 001 | NDA | CIMETIDINE | SUSPENSION;ORAL | 200MG/20ML | No | No | 1999/07/09 | 1999/07/09 | GLAXOSMITHKLINE | Discontinued |