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=ANDA090622"
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
70518-2216-0 70518-2216 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20190715 20250331 ANDA ANDA090622 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 30 TABLET in 1 BLISTER PACK (70518-2216-0)
50383-924-93 50383-924 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 20250331 ANDA ANDA090622 Akorn Operating Company LLC (dba Akorn) BUPRENORPHINE HYDROCHLORIDE 2 mg/1 30 TABLET in 1 BOTTLE (50383-924-93)
0121-2038-30 0121-2038 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20231012 N/A ANDA ANDA090622 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma BUPRENORPHINE HYDROCHLORIDE 8 mg/1 30 TABLET in 1 BOTTLE (0121-2038-30)
50090-1571-0 50090-1571 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20141223 N/A ANDA ANDA090622 A-S Medication Solutions BUPRENORPHINE HYDROCHLORIDE 8 mg/1 30 TABLET in 1 BOTTLE (50090-1571-0)
50383-930-93 50383-930 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 20250331 ANDA ANDA090622 Akorn Operating Company LLC (dba Akorn) BUPRENORPHINE HYDROCHLORIDE 8 mg/1 30 TABLET in 1 BOTTLE (50383-930-93)
0121-1019-30 0121-1019 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20231012 N/A ANDA ANDA090622 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma BUPRENORPHINE HYDROCHLORIDE 2 mg/1 30 TABLET in 1 BOTTLE (0121-1019-30)
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