FDA approved the original new drug application for TIROSINT-SOL on December 15, 2016, sponsored by IBSA. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA206977
- Sponsor
- IBSA
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- levothyroxine sodium
Browse every approval whose brand starts with T, 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 137MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 62.5MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 112MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 37.5MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 88MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 175MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 50MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 13MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 125MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 44MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 100MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 200MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 75MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 150MCG/ML | SOLUTION | ORAL | Prescription |
| levothyroxine sodium 25MCG/ML | SOLUTION | 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.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 3 · Manufacturing (CMC) 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.
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