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=ANDA212378"
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
71610-660-60 71610-660 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20220901 N/A ANDA ANDA212378 Aphena Pharma Solutions - Tennessee, LLC BACLOFEN 10 mg/1 90 TABLET in 1 BOTTLE (71610-660-60)
71610-660-80 71610-660 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20220901 N/A ANDA ANDA212378 Aphena Pharma Solutions - Tennessee, LLC BACLOFEN 10 mg/1 180 TABLET in 1 BOTTLE (71610-660-80)
71610-660-92 71610-660 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20220901 N/A ANDA ANDA212378 Aphena Pharma Solutions - Tennessee, LLC BACLOFEN 10 mg/1 270 TABLET in 1 BOTTLE (71610-660-92)
10135-782-01 10135-782 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20231001 N/A ANDA ANDA212378 Marlex Pharmaceuticals, Inc. BACLOFEN 20 mg/1 100 TABLET in 1 BOTTLE (10135-782-01)
10135-782-05 10135-782 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20231001 N/A ANDA ANDA212378 Marlex Pharmaceuticals, Inc. BACLOFEN 20 mg/1 500 TABLET in 1 BOTTLE (10135-782-05)
10135-782-10 10135-782 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20231001 N/A ANDA ANDA212378 Marlex Pharmaceuticals, Inc. BACLOFEN 20 mg/1 1000 TABLET in 1 BOTTLE (10135-782-10)
58657-931-01 58657-931 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20250601 N/A ANDA ANDA212378 Method Pharmaceuticals LLC BACLOFEN 10 mg/1 10 BLISTER PACK in 1 CARTON (58657-931-01) / 10 TABLET in 1 BLISTER PACK (58657-931-10)
58657-931-05 58657-931 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20250601 N/A ANDA ANDA212378 Method Pharmaceuticals LLC BACLOFEN 10 mg/1 5 BLISTER PACK in 1 CARTON (58657-931-05) / 10 TABLET in 1 BLISTER PACK (58657-931-10)
72162-2374-0 72162-2374 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20240718 N/A ANDA ANDA212378 Bryant Ranch Prepack BACLOFEN 20 mg/1 1000 TABLET in 1 BOTTLE (72162-2374-0)
72162-2374-1 72162-2374 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20240718 N/A ANDA ANDA212378 Bryant Ranch Prepack BACLOFEN 20 mg/1 100 TABLET in 1 BOTTLE (72162-2374-1)
72865-298-01 72865-298 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20250205 N/A ANDA ANDA212378 XLCare Pharmaceuticals Inc. BACLOFEN 20 mg/1 100 TABLET in 1 BOTTLE (72865-298-01)
72865-298-05 72865-298 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20250205 N/A ANDA ANDA212378 XLCare Pharmaceuticals Inc. BACLOFEN 20 mg/1 500 TABLET in 1 BOTTLE (72865-298-05)
72865-298-10 72865-298 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20250205 N/A ANDA ANDA212378 XLCare Pharmaceuticals Inc. BACLOFEN 20 mg/1 1000 TABLET in 1 BOTTLE (72865-298-10)
10135-781-01 10135-781 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20231001 N/A ANDA ANDA212378 Marlex Pharmaceuticals, Inc. BACLOFEN 10 mg/1 100 TABLET in 1 BOTTLE (10135-781-01)
10135-781-10 10135-781 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20231001 N/A ANDA ANDA212378 Marlex Pharmaceuticals, Inc. BACLOFEN 10 mg/1 1000 TABLET in 1 BOTTLE (10135-781-10)
58657-930-01 58657-930 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20250601 N/A ANDA ANDA212378 Method Pharmaceuticals LLC BACLOFEN 5 mg/1 10 BLISTER PACK in 1 CARTON (58657-930-01) / 10 TABLET in 1 BLISTER PACK (58657-930-10)
58657-930-05 58657-930 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20250601 N/A ANDA ANDA212378 Method Pharmaceuticals LLC BACLOFEN 5 mg/1 5 BLISTER PACK in 1 CARTON (58657-930-05) / 10 TABLET in 1 BLISTER PACK (58657-930-10)
72162-2373-0 72162-2373 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20240718 N/A ANDA ANDA212378 Bryant Ranch Prepack BACLOFEN 10 mg/1 1000 TABLET in 1 BOTTLE (72162-2373-0)
72162-2373-1 72162-2373 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20240718 N/A ANDA ANDA212378 Bryant Ranch Prepack BACLOFEN 10 mg/1 100 TABLET in 1 BOTTLE (72162-2373-1)
63629-1227-1 63629-1227 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20201015 N/A ANDA ANDA212378 Bryant Ranch Prepack BACLOFEN 20 mg/1 1000 TABLET in 1 BOTTLE (63629-1227-1)
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