Drug application
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL)
Drugs@FDA ANDA 209242 · HETERO LABS LTD V
Key facts
| Drug name | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL |
| Application type | ANDA |
| Application number | 209242 |
| Company | HETERO LABS LTD V |
| Dosage forms | TABLET, ORAL |
| Strength | EQ 5MG BASE;12.5MG;20MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Oct 6, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 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.