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=NDA214044"
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
52817-615-16 52817-615 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride SOLUTION ORAL 20230125 N/A NDA AUTHORIZED GENERIC NDA214044 TruPharma, LLC TRAMADOL HYDROCHLORIDE 5 mg/mL 473 mL in 1 BOTTLE (52817-615-16)
71511-301-16 71511-301 HUMAN PRESCRIPTION DRUG QDOLO tramadol hydrochloride SOLUTION ORAL 20200911 N/A NDA NDA214044 Athena Bioscience, LLC TRAMADOL HYDROCHLORIDE 5 mg/mL 473 mL in 1 BOTTLE (71511-301-16)
68134-402-40 68134-402 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride SOLUTION ORAL 20210916 N/A NDA AUTHORIZED GENERIC NDA214044 Palmetto Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 5 mg/mL 4 TRAY in 1 CASE (68134-402-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68134-402-05)
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