Levothyroxine Sodium

ANDA 211417, held by Macleods Pharms. Levothyroxine Sodium.

As of Nov 15, 2026, ANDA 211417 (Levothyroxine Sodium), held by Macleods Pharms, was first approved by FDA on Dec 21, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 21, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 21, 2022	Original application	Approved	None posted

Products

12 strengths and forms


Levothyroxine Sodium0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx
Levothyroxine Sodium0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral	Levothyroxine Sodium	Rx

All 2 submissions, including labeling and manufacturing supplements


May 15, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Dec 21, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 211417
Drugs@FDA: Overview at FDA
Company: Macleods 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