Drug application
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Drugs@FDA ANDA 078477 · AMNEAL PHARMS NY
Key facts
| Drug name | AMLODIPINE BESYLATE |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE |
| Application type | ANDA |
| Application number | 078477 |
| Company | AMNEAL PHARMS NY |
| Dosage forms | TABLET, ORAL |
| Strength | EQ 2.5MG BASE |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Jan 16, 2008 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 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.