Tirosint

Manages thyrotropin-dependent well-differentiated thyroid cancer. NDA 21924, held by Ibsa. Levothyroxine Sodium.

As of Nov 14, 2026, NDA 21924 (Tirosint), held by Ibsa, was first approved by FDA on Oct 13, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 13, 2006
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: 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 Hypothyroidi…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 13, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

15 strengths and forms


Tirosint0.025MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.05MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.075MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.1MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.125MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.15MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.112MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.137MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.088MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.175MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.2MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.013MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.0375MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.044MG · capsule;oral	Levothyroxine Sodium	RxReference drug
Tirosint0.0625MG · capsule;oral	Levothyroxine Sodium	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jun 22, 2022	Supplement 21Manufacturing	Approved	Label Letter
Dec 8, 2017	Supplement 13Labeling · Standard review	Approved	Label
Apr 25, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Jul 11, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 4, 2012	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 1, 2008	Supplement 1Labeling · Standard review	Approved	None posted
Dec 17, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 13, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21924
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