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=NDA022512"
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
0597-0108-54 0597-0108 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170707 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 110 mg/1 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE
0597-0108-60 0597-0108 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20151123 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 110 mg/1 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK
0597-0355-09 0597-0355 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170728 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 75 mg/1 1 BOTTLE in 1 CARTON (0597-0355-09) / 60 CAPSULE in 1 BOTTLE
0597-0355-56 0597-0355 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170728 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 75 mg/1 60 BLISTER PACK in 1 CARTON (0597-0355-56) / 1 CAPSULE in 1 BLISTER PACK
0597-0360-55 0597-0360 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170728 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 1 BOTTLE in 1 CARTON (0597-0360-55) / 60 CAPSULE in 1 BOTTLE
0597-0360-82 0597-0360 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170728 N/A NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 60 BLISTER PACK in 1 CARTON (0597-0360-82) / 1 CAPSULE in 1 BLISTER PACK
50090-4480-0 50090-4480 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20190828 N/A NDA NDA022512 A-S Medication Solutions DABIGATRAN ETEXILATE MESYLATE 150 mg/1 1 BOTTLE in 1 CARTON (50090-4480-0) / 60 CAPSULE in 1 BOTTLE
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