0597-0295-61 |
0597-0295 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
25 mg/1; 1000 mg/1 |
1 BOTTLE in 1 CARTON (0597-0295-61) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE |
0597-0295-78 |
0597-0295 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
25 mg/1; 1000 mg/1 |
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-78) |
0597-0295-88 |
0597-0295 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
25 mg/1; 1000 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-88) |
0597-0290-20 |
0597-0290 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
20250331 |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
5 mg/1; 1000 mg/1 |
1 BOTTLE in 1 CARTON (0597-0290-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
0597-0290-59 |
0597-0290 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
5 mg/1; 1000 mg/1 |
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0290-59) |
0597-0290-74 |
0597-0290 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
5 mg/1; 1000 mg/1 |
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0290-74) |
0597-0300-20 |
0597-0300 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
12.5 mg/1; 1000 mg/1 |
1 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
0597-0300-45 |
0597-0300 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
12.5 mg/1; 1000 mg/1 |
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45) |
0597-0300-93 |
0597-0300 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
12.5 mg/1; 1000 mg/1 |
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93) |
0597-0280-36 |
0597-0280 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
20250331 |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
10 mg/1; 1000 mg/1 |
1 BOTTLE in 1 CARTON (0597-0280-36) / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE |
0597-0280-73 |
0597-0280 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
10 mg/1; 1000 mg/1 |
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-73) |
0597-0280-90 |
0597-0280 |
HUMAN PRESCRIPTION DRUG |
Synjardy XR |
empagliflozin, metformin hydrochloride |
TABLET, EXTENDED RELEASE |
ORAL |
20161210 |
N/A |
NDA |
NDA208658 |
Boehringer Ingelheim Pharmaceuticals, Inc. |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
10 mg/1; 1000 mg/1 |
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0280-90) |