Levoxyl

Manages well-differentiated thyroid cancer. NDA 21301, held by King Pharms. Levothyroxine Sodium.

As of Nov 14, 2026, NDA 21301 (Levoxyl), held by King Pharms, was first approved by FDA on May 25, 2001, with 12 approved supplements and 0 published complete response letters.

First approved: May 25, 2001
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients 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. 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 13 submissions below

Date	Submission	Status	Documents
May 25, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

12 strengths and forms


Levoxyl0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	RxReference drug
Levoxyl0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levothyroxine Sodium	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Dec 20, 2018	Supplement 38Labeling · Standard review	Approved	Label
Nov 5, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
May 6, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 14, 2012	Supplement 34Manufacturing · Standard review	Approved	None posted
Mar 21, 2011	Supplement 27Manufacturing	Approved	Label
Sep 1, 2009	Supplement 28	Approved	Review
Jul 8, 2008	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 8, 2005	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 23, 2003	Supplement 6Manufacturing · Standard review	Approved	Letter
Dec 31, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 17, 2002	Supplement 2Labeling · Standard review	Approved	Letter
Apr 3, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
May 25, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21301
Drugs@FDA: Overview at FDA
Company: King Pharmaceuticals

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