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=NDA019618"
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
62559-420-07 62559-420 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20160513 N/A NDA AUTHORIZED GENERIC NDA019618 ANI Pharmaceuticals, Inc. MESALAMINE 4 g/60mL 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11)
0037-0022-07 0037-0022 HUMAN PRESCRIPTION DRUG sfRowasa Sulfite-Free Formulation mesalamine SUSPENSION RECTAL 20160324 N/A NDA NDA019618 Meda Pharmaceuticals Inc. MESALAMINE 4 g/60mL 7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
0037-0022-28 0037-0022 HUMAN PRESCRIPTION DRUG sfRowasa Sulfite-Free Formulation mesalamine SUSPENSION RECTAL 20160524 N/A NDA NDA019618 Meda Pharmaceuticals Inc. MESALAMINE 4 g/60mL 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)
0037-0066-03 0037-0066 HUMAN PRESCRIPTION DRUG Rowasa mesalamine SUSPENSION RECTAL 20160324 N/A NDA NDA019618 Meda Pharmaceuticals Inc. MESALAMINE 4 g/60mL 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
0037-0066-05 0037-0066 HUMAN PRESCRIPTION DRUG Rowasa mesalamine SUSPENSION RECTAL 20160324 N/A NDA NDA019618 Meda Pharmaceuticals Inc. MESALAMINE 4 g/60mL 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
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