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=ANDA212797"
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
71034-003-30 71034-003 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20210611 N/A ANDA ANDA212797 Xiamen LP Pharmaceutical Co., Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)
71034-002-30 71034-002 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20210611 N/A ANDA ANDA212797 Xiamen LP Pharmaceutical Co., Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-002-30)
69680-146-30 69680-146 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20210827 N/A ANDA ANDA212797 Vitruvias Therapeutics, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30)
69680-145-30 69680-145 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20210827 N/A ANDA ANDA212797 Vitruvias Therapeutics, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-145-30)
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