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=NDA209478"
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
46287-020-01 46287-020 HUMAN PRESCRIPTION DRUG CaroSpir CaroSpir SUSPENSION ORAL 20170804 N/A NDA NDA209478 CMP Pharma, Inc. SPIRONOLACTONE 25 mg/5mL 473 mL in 1 BOTTLE (46287-020-01)
46287-020-04 46287-020 HUMAN PRESCRIPTION DRUG CaroSpir CaroSpir SUSPENSION ORAL 20170804 N/A NDA NDA209478 CMP Pharma, Inc. SPIRONOLACTONE 25 mg/5mL 118 mL in 1 BOTTLE (46287-020-04)
46287-020-50 46287-020 HUMAN PRESCRIPTION DRUG CaroSpir CaroSpir SUSPENSION ORAL 20210715 N/A NDA NDA209478 CMP Pharma, Inc. SPIRONOLACTONE 25 mg/5mL 10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE
17856-0120-1 17856-0120 HUMAN PRESCRIPTION DRUG CaroSpir CaroSpir SUSPENSION ORAL 20240412 N/A NDA NDA209478 ATLANTIC BIOLOGICALS CORP. SPIRONOLACTONE 25 mg/5mL 72 CUP in 1 BOX (17856-0120-1) / 2.5 mL in 1 CUP (17856-0120-2)
17856-1133-1 17856-1133 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE spironolactone SUSPENSION ORAL 20240603 N/A NDA AUTHORIZED GENERIC NDA209478 ATLANTIC BIOLOGICALS CORP. SPIRONOLACTONE 25 mg/5mL 1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE
0574-1133-04 0574-1133 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE spironolactone SUSPENSION ORAL 20231031 N/A NDA AUTHORIZED GENERIC NDA209478 Padagis US LLC SPIRONOLACTONE 25 mg/5mL 118 mL in 1 BOTTLE (0574-1133-04)
0574-1133-10 0574-1133 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE spironolactone SUSPENSION ORAL 20231031 N/A NDA AUTHORIZED GENERIC NDA209478 Padagis US LLC SPIRONOLACTONE 25 mg/5mL 10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)
0574-1133-16 0574-1133 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE spironolactone SUSPENSION ORAL 20231031 N/A NDA AUTHORIZED GENERIC NDA209478 Padagis US LLC SPIRONOLACTONE 25 mg/5mL 473 mL in 1 BOTTLE (0574-1133-16)
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