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=NDA209410"
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
70482-075-07 70482-075 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 129 mg/1 2 BLISTER PACK in 1 CARTON (70482-075-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
70482-075-14 70482-075 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 129 mg/1 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14)
70482-075-30 70482-075 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 129 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-30)
70482-076-07 70482-076 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 193 mg/1 2 BLISTER PACK in 1 CARTON (70482-076-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
70482-076-14 70482-076 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 193 mg/1 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-14)
70482-076-30 70482-076 HUMAN PRESCRIPTION DRUG OSMOLEX ER amantadine TABLET, EXTENDED RELEASE ORAL 20180601 N/A NDA NDA209410 Adamas Pharma, LLC AMANTADINE HYDROCHLORIDE 193 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-30)
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