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=NDA021278"
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
66758-250-01 66758-250 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20240816 N/A NDA NDA021278 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 100 TABLET in 1 BOTTLE (66758-250-01)
0078-0380-05 0078-0380 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 N/A NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 100 TABLET in 1 BOTTLE (0078-0380-05)
66758-252-01 66758-252 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20240712 N/A NDA NDA021278 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 100 TABLET in 1 BOTTLE (66758-252-01)
0078-0381-05 0078-0381 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 N/A NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 100 TABLET in 1 BOTTLE (0078-0381-05)
0078-0382-05 0078-0382 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 N/A NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 100 TABLET in 1 BOTTLE (0078-0382-05)
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