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=ANDA203326"
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
70518-3844-0 70518-3844 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20230829 N/A ANDA ANDA203326 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8 mg/1; 2 mg/1 30 TABLET in 1 BLISTER PACK (70518-3844-0)
0904-7009-06 0904-7009 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 N/A ANDA ANDA203326 Major Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1; .5 mg/1 50 BLISTER PACK in 1 CARTON (0904-7009-06) / 1 TABLET in 1 BLISTER PACK
0904-7010-06 0904-7010 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 N/A ANDA ANDA203326 Major Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8 mg/1; 2 mg/1 50 BLISTER PACK in 1 CARTON (0904-7010-06) / 1 TABLET in 1 BLISTER PACK
0054-0189-13 0054-0189 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 N/A ANDA ANDA203326 Hikma Pharmaceuticals USA Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8 mg/1; 2 mg/1 30 TABLET in 1 BOTTLE (0054-0189-13)
0054-0188-13 0054-0188 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 N/A ANDA ANDA203326 Hikma Pharmaceuticals USA Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1; .5 mg/1 30 TABLET in 1 BOTTLE (0054-0188-13)
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