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=ANDA075060"
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
0116-4010-16 0116-4010 HUMAN PRESCRIPTION DRUG Amantadine Amantadine SOLUTION ORAL 20241105 N/A ANDA ANDA075060 Xttrium Laboratories, Inc AMANTADINE HYDROCHLORIDE 50 mg/5mL 473 mL in 1 BOTTLE (0116-4010-16)
0116-4010-41 0116-4010 HUMAN PRESCRIPTION DRUG Amantadine Amantadine SOLUTION ORAL 20241105 N/A ANDA ANDA075060 Xttrium Laboratories, Inc AMANTADINE HYDROCHLORIDE 50 mg/5mL 100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)
17856-0093-1 17856-0093 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE SOLUTION ORAL 20240508 N/A ANDA ANDA075060 ATLANTIC BIOLOGICALS CORP. AMANTADINE HYDROCHLORIDE 50 mg/5mL 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0093-1) / 10 mL in 1 CUP, UNIT-DOSE
17856-0093-3 17856-0093 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE SOLUTION ORAL 20240508 N/A ANDA ANDA075060 ATLANTIC BIOLOGICALS CORP. AMANTADINE HYDROCHLORIDE 50 mg/5mL 5 mL in 1 CUP, UNIT-DOSE (17856-0093-3)
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