Drug application
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM)
Drugs@FDA ANDA 217279 · ALEMBIC
Key facts
| Drug name | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM |
|---|---|
| Active ingredients | AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM |
| Application type | ANDA |
| Application number | 217279 |
| Company | ALEMBIC |
| Dosage forms | TABLET, ORAL |
| Strength | EQ 2.5MG BASE;EQ 10MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | May 22, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 10–99 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.