Drug application
BEMPEDOIC ACID (BEMPEDOIC ACID)
Drugs@FDA ANDA 219416 · ALKEM LABORATORIES LIMITED
Key facts
| Drug name | BEMPEDOIC ACID |
|---|---|
| Active ingredients | BEMPEDOIC ACID |
| Application type | ANDA |
| Application number | 219416 |
| Company | ALKEM LABORATORIES LIMITED |
| Dosage forms | TABLET |
| Strength | 180MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Nov 4, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- None 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.