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=ANDA204431"
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
0121-1018-30 0121-1018 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20230905 N/A ANDA ANDA204431 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2 mg/1; .5 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (0121-1018-30)
0121-2036-30 0121-2036 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20230905 N/A ANDA ANDA204431 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8 mg/1; 2 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30)
50383-287-93 50383-287 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160107 20250331 ANDA ANDA204431 Akorn Operating Company LLC (dba Akorn) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8 mg/1; 2 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (50383-287-93)
50383-294-93 50383-294 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160107 20250331 ANDA ANDA204431 Akorn Operating Company LLC (dba Akorn) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2 mg/1; .5 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (50383-294-93)
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