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=ANDA210377"
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
33342-579-96 33342-579 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate KIT 20250627 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited 1 KIT in 1 KIT (33342-579-96) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95)
33342-350-09 33342-350 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate CAPSULE, DELAYED RELEASE ORAL 20240626 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited DIMETHYL FUMARATE 240 mg/1 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-09)
33342-350-95 33342-350 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate CAPSULE, DELAYED RELEASE ORAL 20250627 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited DIMETHYL FUMARATE 240 mg/1 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95)
33342-349-09 33342-349 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate CAPSULE, DELAYED RELEASE ORAL 20240626 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited DIMETHYL FUMARATE 120 mg/1 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09)
33342-349-94 33342-349 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate CAPSULE, DELAYED RELEASE ORAL 20250627 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited DIMETHYL FUMARATE 120 mg/1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94)
33342-349-97 33342-349 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate CAPSULE, DELAYED RELEASE ORAL 20240626 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited DIMETHYL FUMARATE 120 mg/1 1 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
33342-351-93 33342-351 HUMAN PRESCRIPTION DRUG Dimethyl Fumarate Dimethyl Fumarate KIT 20240626 N/A ANDA ANDA210377 Macleods Pharmaceuticals Limited 1 KIT in 1 KIT (33342-351-93) * 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-349-91) * 23 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-350-92)
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