Manages well-differentiated thyroid cancer Thyroid Suppression Test. ANDA 91382, held by Sun Pharm. Liothyronine Sodium.
As of Nov 15, 2026, ANDA 91382 (Liothyronine Sodium), held by Sun Pharm, was first approved by FDA on Apr 20, 2016, with 1 approved supplement and 0 published complete response letters.
Liothyronine is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2016 | Original application | Approved |
| Liothyronine SodiumEQ 0.005MG BASE · tablet;oral | Liothyronine Sodium | Rx |
| Liothyronine SodiumEQ 0.025MG BASE · tablet;oral | Liothyronine Sodium | Rx |
| Liothyronine SodiumEQ 0.05MG BASE · tablet;oral | Liothyronine Sodium | Rx |
| May 17, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 20, 2016 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
