Drug application
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE, CANAGLIFLOZIN)
Drugs@FDA ANDA 215255 · MACLEODS PHARMACEUTICALS LTD
Key facts
| Drug name | CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
|---|---|
| Active ingredients | METFORMIN HYDROCHLORIDE, CANAGLIFLOZIN |
| Application type | ANDA |
| Application number | 215255 |
| Company | MACLEODS PHARMACEUTICALS LTD |
| Dosage forms | TABLET, EXTENDED RELEASE |
| Strength | 1000MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Oct 1, 2025 |
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.