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) |