美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PEPCID AC"
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NDA FAMOTIDINE TABLET, CHEWABLE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/09/24 1998/09/24 KENVUE BRANDS Discontinued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
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