Drug application
HYDROCHLOROTHIAZIDE; IRBESARTAN (HYDROCHLOROTHIAZIDE, IRBESARTAN)
Drugs@FDA ANDA 201616 · CIPLA LIMITED
Key facts
| Drug name | HYDROCHLOROTHIAZIDE; IRBESARTAN |
|---|---|
| Active ingredients | HYDROCHLOROTHIAZIDE, IRBESARTAN |
| Application type | ANDA |
| Application number | 201616 |
| Company | CIPLA LIMITED |
| Dosage forms | TABLET, ORAL |
| Strength | 12.5MG; 150MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Sep 28, 2012 |
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.