Drug application
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Drugs@FDA ANDA 216370 · ALEMBIC
Key facts
| Drug name | LEVOTHYROXINE SODIUM |
|---|---|
| Active ingredients | LEVOTHYROXINE SODIUM |
| Application type | ANDA |
| Application number | 216370 |
| Company | ALEMBIC |
| Dosage forms | TABLET, ORAL |
| Strength | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium |
| Marketing status | Prescription |
| TE codes | AB2 |
| Reference listed drug | No |
| Latest submission status date | May 20, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 10–99 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.