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=NDA215602"
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
72162-2342-2 72162-2342 HUMAN PRESCRIPTION DRUG Baclofen baclofen SUSPENSION ORAL 20240701 N/A NDA AUTHORIZED GENERIC NDA215602 Bryant Ranch Prepack BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (72162-2342-2) / 120 mL in 1 BOTTLE
72162-2342-4 72162-2342 HUMAN PRESCRIPTION DRUG Baclofen baclofen SUSPENSION ORAL 20240701 N/A NDA AUTHORIZED GENERIC NDA215602 Bryant Ranch Prepack BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (72162-2342-4) / 300 mL in 1 BOTTLE
52536-600-11 52536-600 HUMAN PRESCRIPTION DRUG Baclofen baclofen SUSPENSION ORAL 20230401 N/A NDA AUTHORIZED GENERIC NDA215602 Wilshire Pharmaceuticals, Inc. BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE
52536-600-12 52536-600 HUMAN PRESCRIPTION DRUG Baclofen baclofen SUSPENSION ORAL 20230401 N/A NDA AUTHORIZED GENERIC NDA215602 Wilshire Pharmaceuticals, Inc. BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE
52652-6001-1 52652-6001 HUMAN PRESCRIPTION DRUG FLEQSUVY baclofen SUSPENSION ORAL 20220207 N/A NDA NDA215602 Azurity Pharmaceuticals, Inc. BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLE
52652-6001-2 52652-6001 HUMAN PRESCRIPTION DRUG FLEQSUVY baclofen SUSPENSION ORAL 20220207 N/A NDA NDA215602 Azurity Pharmaceuticals, Inc. BACLOFEN 5 mg/mL 1 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE
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