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=ANDA210819"
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
76385-107-10 76385-107 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20190515 N/A ANDA ANDA210819 Bayshore Pharmaceuticals, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 1000 TABLET in 1 BOTTLE (76385-107-10)
76385-107-01 76385-107 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20190515 N/A ANDA ANDA210819 Bayshore Pharmaceuticals, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 100 TABLET in 1 BOTTLE (76385-107-01)
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