Tirosint-Sol

Manages thyrotropin-dependent well-differentiated thyroid cancer. NDA 206977, held by Ibsa. Levothyroxine Sodium.

As of Nov 13, 2026, NDA 206977 (Tirosint-Sol), held by Ibsa, was first approved by FDA on Dec 15, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TIROSINT-SOL is L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: Hypothyroidism - As replacement therapy 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 thyrotropin-dependent well-differentiated thyroid cancer Limitations of Use Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis Hypothyro…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 15, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Medical Review

Products

15 strengths and forms


Tirosint-Sol13MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol25MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol50MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol75MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol88MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol100MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol112MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol125MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol137MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol150MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol175MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol200MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol37.5MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol44MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug
Tirosint-Sol62.5MCG/ML · solution;oral	Levothyroxine Sodium	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Nov 16, 2023	Supplement 10Labeling · Standard review	Approved	Label Letter
Nov 16, 2023	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 13, 2021	Supplement 9Manufacturing	Approved	Letter Label
Feb 24, 2017	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 15, 2016	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Medical Review

Identifiers

Application: NDA 206977
Drugs@FDA: Overview at FDA
Company: IBSA Institut Biochimique SA

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