FdaApplication
NDA 200678
Identifiers
- fda_app_no: NDA200678
Properties
| Property | Value |
|---|---|
| applicant_name | ASTRAZENECA AB |
| application_type | NDA |
| approval_date | 2010-11-05 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
3 products