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=ANDA217903"
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
69315-320-10 69315-320 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION AURICULAR (OTIC) 20240301 N/A ANDA ANDA217903 Leading Pharma, LLC OFLOXACIN 3 mg/mL 10 mL in 1 BOTTLE, DROPPER (69315-320-10)
69315-320-05 69315-320 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION AURICULAR (OTIC) 20240301 N/A ANDA ANDA217903 Leading Pharma, LLC OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (69315-320-05)
65145-144-01 65145-144 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin Otic solution SOLUTION/ DROPS AURICULAR (OTIC) 20240109 N/A ANDA ANDA217903 Caplin Steriles Limited OFLOXACIN 3 mg/mL 1 BOTTLE, DROPPER in 1 CARTON (65145-144-01) / 10 mL in 1 BOTTLE, DROPPER
65145-143-01 65145-143 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin Otic SOLUTION/ DROPS AURICULAR (OTIC) 20240109 N/A ANDA ANDA217903 Caplin Steriles Limited OFLOXACIN 3 mg/mL 1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPER
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