Drug application
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE)
Drugs@FDA ANDA 078652 · ZYDUS PHARMS USA INC
Key facts
| Drug name | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 078652 |
| Company | ZYDUS PHARMS USA INC |
| Dosage forms | CAPSULE, ORAL |
| Strength | 2.5MG; 10MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Mar 28, 2013 |
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.