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=ANDA200503"
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
80425-0312-3 80425-0312 HUMAN PRESCRIPTION DRUG Tramadol HCL ER Tramadol HCL TABLET, EXTENDED RELEASE ORAL 20230407 N/A ANDA ANDA200503 Advanced Rx Pharmacy of Tennessee, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0312-3)
76420-538-30 76420-538 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20230216 N/A ANDA ANDA200503 Asclemed USA, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-538-30)
45865-184-30 45865-184 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20210528 N/A ANDA ANDA200503 Medsource Pharmaceuticals TRAMADOL HYDROCHLORIDE 300 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30)
76420-538-60 76420-538 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20230216 N/A ANDA ANDA200503 Asclemed USA, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-538-60)
76420-538-90 76420-538 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20230216 N/A ANDA ANDA200503 Asclemed USA, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-538-90)
67046-1527-3 67046-1527 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20250227 N/A ANDA ANDA200503 Coupler LLC TRAMADOL HYDROCHLORIDE 100 mg/1 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1527-3)
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