Drug application
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Drugs@FDA ANDA 219686 · TEVA PHARMS INC
Key facts
| Drug name | AMLODIPINE BESYLATE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE |
| Application type | ANDA |
| Application number | 219686 |
| Company | TEVA PHARMS INC |
| Dosage forms | TABLET, ORAL |
| Strength | EQ 2.5MG BASE |
| Marketing status | Discontinued |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Jan 22, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 10–99 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.