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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ZANTAC 75 | 020520 | 001 | NDA | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE | Yes | No | 1995/12/19 | 1995/12/19 | CHATTEM SANOFI | Discontinued |
ZANTAC 75 | 020745 | 001 | NDA | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/02/26 | 1998/02/26 | CHATTEM SANOFI | Discontinued |