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=NDA019452"
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
68791-102-01 68791-102 HUMAN PRESCRIPTION DRUG DERMA-SMOOTHE/FS fluocinolone acetonide OIL TOPICAL 20230817 N/A NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL 1 BOTTLE in 1 CARTON (68791-102-01) / 20 mL in 1 BOTTLE
68791-102-04 68791-102 HUMAN PRESCRIPTION DRUG DERMA-SMOOTHE/FS fluocinolone acetonide OIL TOPICAL 19950216 N/A NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL 1 BOTTLE in 1 CARTON (68791-102-04) / 118.28 mL in 1 BOTTLE
68791-103-20 68791-103 HUMAN PRESCRIPTION DRUG DERMOTIC fluocinolone acetonide OIL AURICULAR (OTIC) 20051109 N/A NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER
68791-101-04 68791-101 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 N/A NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE
68791-101-01 68791-101 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 20240506 N/A NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE
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