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=NDA208251"
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
42195-128-14 42195-128 HUMAN PRESCRIPTION DRUG Ciprofloxacin and Fluocinolone Acetonide ciprofloxacin and fluocinolone acetonide SOLUTION AURICULAR (OTIC) 20211004 N/A NDA AUTHORIZED GENERIC NDA208251 Xspire Pharma, LLC CIPROFLOXACIN; FLUOCINOLONE ACETONIDE .75 mg/.25mL; .0625 mg/.25mL 1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
66992-128-14 66992-128 HUMAN PRESCRIPTION DRUG OTOVEL ciprofloxacin and fluocinolone acetonide SOLUTION AURICULAR (OTIC) 20211004 N/A NDA NDA208251 WraSer LLC CIPROFLOXACIN; FLUOCINOLONE ACETONIDE .75 mg/.25mL; .0625 mg/.25mL 1 POUCH in 1 CARTON (66992-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
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