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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
PEPCID AC | 020325 | 001 | NDA | FAMOTIDINE | TABLET;ORAL | 10MG | Yes | No | 1995/04/28 | 1995/04/28 | KENVUE BRANDS | Over-the-counter |
PEPCID AC | 020325 | 002 | NDA | FAMOTIDINE | TABLET;ORAL | 20MG | Yes | Yes | 1995/04/28 | 2003/09/23 | KENVUE BRANDS | Over-the-counter |
PEPCID AC | 020801 | 001 | NDA | FAMOTIDINE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/09/24 | 1998/09/24 | KENVUE BRANDS | Discontinued |
PEPCID AC | 020801 | 002 | NDA | FAMOTIDINE | TABLET, CHEWABLE;ORAL | 20MG | Yes | Yes | 1998/09/24 | 2007/12/17 | KENVUE BRANDS | Over-the-counter |
PEPCID AC | 020902 | 001 | NDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 1999/08/05 | 1999/08/05 | J AND J CONSUMER INC | Over-the-counter |