Drug application
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE, SITAGLIPTIN)
Drugs@FDA ANDA 214494 · APOTEX INC
Key facts
| Drug name | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
|---|---|
| Active ingredients | METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
| Application type | ANDA |
| Application number | 214494 |
| Company | APOTEX INC |
| Dosage forms | TABLET, EXTENDED RELEASE |
| Strength | 100MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Mar 10, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.