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=ANDA202019"
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
0378-5090-73 0378-5090 HUMAN PRESCRIPTION DRUG Varenicline Varenicline TABLET, FILM COATED ORAL 20240314 N/A ANDA ANDA202019 Mylan Pharmaceuticals Inc. VARENICLINE TARTRATE 1 mg/1 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5090-73)
0378-5089-73 0378-5089 HUMAN PRESCRIPTION DRUG Varenicline Varenicline TABLET, FILM COATED ORAL 20240314 N/A ANDA ANDA202019 Mylan Pharmaceuticals Inc. VARENICLINE TARTRATE .5 mg/1 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5089-73)
0378-5091-85 0378-5091 HUMAN PRESCRIPTION DRUG Varenicline Varenicline KIT 20240314 N/A ANDA ANDA202019 Mylan Pharmaceuticals Inc. 1 KIT in 1 KIT (0378-5091-85) * 11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46) * 42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)
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