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=NDA205649"
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
0310-6225-60 0310-6225 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180115 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 2.5 mg/1; 1000 mg/1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6225-60)
0310-6250-30 0310-6250 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141201 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5 mg/1; 500 mg/1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6250-30)
0310-6260-60 0310-6260 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141111 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5 mg/1; 1000 mg/1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60)
0310-6260-95 0310-6260 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141111 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5 mg/1; 1000 mg/1 1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
0310-6270-30 0310-6270 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141111 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10 mg/1; 500 mg/1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6270-30)
0310-6280-30 0310-6280 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141111 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10 mg/1; 1000 mg/1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6280-30)
0310-6280-95 0310-6280 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141111 N/A NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10 mg/1; 1000 mg/1 1 BLISTER PACK in 1 CARTON (0310-6280-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
66993-362-30 66993-362 HUMAN PRESCRIPTION DRUG dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20240103 N/A NDA AUTHORIZED GENERIC NDA205649 PRASCO, LLC DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10 mg/1; 1000 mg/1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-362-30)
66993-361-60 66993-361 HUMAN PRESCRIPTION DRUG dapagliflozin and metformin hydrochloride dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20240103 N/A NDA AUTHORIZED GENERIC NDA205649 PRASCO, LLC DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5 mg/1; 1000 mg/1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)
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