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=ANDA211045"
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
52605-068-13 52605-068 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20201201 N/A ANDA ANDA211045 POLYGEN PHARMACEUTICALS INC. DARIFENACIN HYDROBROMIDE 15 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)
52605-068-19 52605-068 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20201201 N/A ANDA ANDA211045 POLYGEN PHARMACEUTICALS INC. DARIFENACIN HYDROBROMIDE 15 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-19)
52605-068-10 52605-068 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20201201 N/A ANDA ANDA211045 POLYGEN PHARMACEUTICALS INC. DARIFENACIN HYDROBROMIDE 15 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-10)
52605-067-19 52605-067 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20201201 N/A ANDA ANDA211045 POLYGEN PHARMACEUTICALS INC. DARIFENACIN HYDROBROMIDE 7.5 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19)
52605-067-10 52605-067 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20201201 N/A ANDA ANDA211045 POLYGEN PHARMACEUTICALS INC. DARIFENACIN HYDROBROMIDE 7.5 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10)
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