FdaApplication
NDA 208658
Identifiers
- fda_app_no: NDA208658
Properties
| Property | Value |
|---|---|
| applicant_name | BOEHRINGER INGELHEIM PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2016-12-09 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 12.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
| SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
| SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
| SYNJARDY XR | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 25MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
4 products