FDA approved the original new drug application for UNITHROID on August 21, 2000, sponsored by STEVENS J. FDA has approved 2 efficacy supplements on the application since, the most recent on December 13, 2004.
- Application
- NDA021210
- Sponsor
- STEVENS J
- Original approval
- Review
- standard review
- Submission class
- Type 7 - Drug Already Marketed without Approved NDA
- Active ingredient
- levothyroxine sodium
Browse every approval whose brand starts with U, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| levothyroxine sodium 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
| levothyroxine sodium 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | — | |
| S-3 | — |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 4 · Labeling 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to STEVENS J
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