Levothyroxine Sodium

Treats myxedema coma. NDA 202231, held by Fresenius Kabi USA. Levothyroxine Sodium.

As of Nov 13, 2026, NDA 202231 (Levothyroxine Sodium), held by Fresenius Kabi USA, was first approved by FDA on Jun 24, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 24, 2011
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 24, 2011	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Levothyroxine Sodium100MCG/VIAL · powder;intravenous	Levothyroxine Sodium	RxReference drug
Levothyroxine Sodium200MCG/VIAL · powder;intravenous	Levothyroxine Sodium	RxReference drug
Levothyroxine Sodium500MCG/VIAL · powder;intravenous	Levothyroxine Sodium	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Oct 21, 2026	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 6, 2026	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 4, 2014	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 26, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 16, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 20, 2012	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 24, 2011	Original applicationTYPE 7 · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202231
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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