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=ANDA076527"
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
63629-8716-1 63629-8716 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20210819 N/A ANDA ANDA076527 Bryant Ranch Prepack OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (63629-8716-1)
63187-184-05 63187-184 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20190101 N/A ANDA ANDA076527 Proficient Rx LP OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (63187-184-05)
67296-0344-1 67296-0344 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 N/A ANDA ANDA076527 Redpharm Drug OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (67296-0344-1)
72189-108-05 72189-108 HUMAN PRESCRIPTION DRUG OFLOXACIN OTIC OFLOXACIN SOLUTION AURICULAR (OTIC) 20200608 N/A ANDA ANDA076527 DIRECT RX OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (72189-108-05)
53002-2604-1 53002-2604 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20181001 N/A ANDA ANDA076527 RPK Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (53002-2604-1)
60505-0363-1 60505-0363 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 N/A ANDA ANDA076527 Apotex Corp. OFLOXACIN 3 mg/mL 5 mL in 1 BOTTLE, DROPPER (60505-0363-1)
60505-0363-2 60505-0363 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 N/A ANDA ANDA076527 Apotex Corp. OFLOXACIN 3 mg/mL 10 mL in 1 BOTTLE, DROPPER (60505-0363-2)
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