Thyro-Tabs

Manages thyrotropin-dependent well-differentiated thyroid cancer. NDA 21116, held by Alvogen. Levothyroxine Sodium.

As of Nov 14, 2026, NDA 21116 (Thyro-Tabs), held by Alvogen, was first approved by FDA on Oct 24, 2002, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 24, 2002
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated 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 hypothyroidism during the recovery phase of subacute thyroiditis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Apr 14, 2022	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 13, 2021	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter
May 19, 2016	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 24, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

12 strengths and forms


Thyro-Tabs0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Thyro-Tabs0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 16, 2023	Supplement 27Labeling · Standard review	Approved	Label Letter
Apr 14, 2022	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 13, 2021	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter
Apr 23, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 31, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
May 19, 2016	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter
Nov 9, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 13, 2015	Supplement 12Labeling · Standard review	Approved	Review
Mar 10, 2006	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 7, 2004	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 24, 2002	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21116
Drugs@FDA: Overview at FDA
Company: Alvogen

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