Drug application
AMLODIPINE BENZOATE (AMLODIPINE BENZOATE)
Drugs@FDA ANDA 215035 · AMNEAL
Key facts
| Drug name | AMLODIPINE BENZOATE |
|---|---|
| Active ingredients | AMLODIPINE BENZOATE |
| Application type | ANDA |
| Application number | 215035 |
| Company | AMNEAL |
| Dosage forms | SUSPENSION, ORAL |
| Strength | EQ 1MG BASE/ML |
| Marketing status | Discontinued |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Jun 13, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: