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=NDA021802"
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
0078-0430-05 0078-0430 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
0078-0431-05 0078-0431 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)
0078-0432-05 0078-0432 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0432-05)
0078-0433-05 0078-0433 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05)
0078-0434-05 0078-0434 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0434-05)
0078-0493-05 0078-0493 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0493-05)
0078-0608-05 0078-0608 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0608-05)
0078-0609-05 0078-0609 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 N/A NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0609-05)
0781-2682-01 0781-2682 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141120 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2682-01)
0781-2683-01 0781-2683 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150203 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2683-01)
0781-2684-01 0781-2684 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140128 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2684-01)
0781-2685-01 0781-2685 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150622 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2685-01)
0781-2686-01 0781-2686 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2686-01)
0781-2687-01 0781-2687 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140114 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2687-01)
0781-2688-01 0781-2688 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2688-01)
0781-2689-01 0781-2689 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140305 N/A NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2689-01)
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