Drug application
IRBESARTAN; HYDROCHLOROTHIAZIDE (IRBESARTAN, HYDROCHLOROTHIAZIDE)
Drugs@FDA ANDA 090815 · ZYDUS PHARMS USA INC
Key facts
| Drug name | IRBESARTAN; HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | IRBESARTAN, HYDROCHLOROTHIAZIDE |
| Application type | ANDA |
| Application number | 090815 |
| Company | ZYDUS PHARMS USA INC |
| Dosage forms | TABLET, ORAL |
| Strength | 150MG; 12.5MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Feb 16, 2011 |
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.