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=ANDA078403"
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
0615-8487-05 0615-8487 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20230816 N/A ANDA ANDA078403 NCS HealthCare of KY, LLC dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8487-05)
0615-8487-28 0615-8487 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20240424 N/A ANDA ANDA078403 NCS HealthCare of KY, LLC dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8487-28)
0615-8487-30 0615-8487 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20231103 N/A ANDA ANDA078403 NCS HealthCare of KY, LLC dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8487-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK
0615-8487-39 0615-8487 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20230816 N/A ANDA ANDA078403 NCS HealthCare of KY, LLC dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8487-39)
70010-203-05 70010-203 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20230515 N/A ANDA ANDA078403 Granules Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (70010-203-05)
70010-203-09 70010-203 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20230515 N/A ANDA ANDA078403 Granules Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (70010-203-09)
70010-203-10 70010-203 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20230515 N/A ANDA ANDA078403 Granules Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 1000 TABLET, FILM COATED in 1 BOTTLE (70010-203-10)
70518-4157-0 70518-4157 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20240813 N/A ANDA ANDA078403 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4157-0)
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