美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA214358"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
0597-0425-78 0597-0425 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 20 mg/1 1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG
0597-0445-87 0597-0445 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 110 mg/1 1 BAG in 1 CARTON (0597-0445-87) / 60 PELLET in 1 BAG
0597-0435-96 0597-0435 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 40 mg/1 1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG
0597-0440-53 0597-0440 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 50 mg/1 1 BAG in 1 CARTON (0597-0440-53) / 60 PELLET in 1 BAG
0597-0430-18 0597-0430 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 30 mg/1 1 BAG in 1 CARTON (0597-0430-18) / 60 PELLET in 1 BAG
0597-0450-16 0597-0450 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate PELLET ORAL 20220316 N/A NDA NDA214358 Boehringer Ingelheim Pharmaceuticals, Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 1 BAG in 1 CARTON (0597-0450-16) / 60 PELLET in 1 BAG
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