Levothyroxine Sodium

ANDA 76752, held by Merck Kgaa. Levothyroxine Sodium.

As of Nov 15, 2026, ANDA 76752 (Levothyroxine Sodium), held by Merck Kgaa, was first approved by FDA on Jun 16, 2005, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 16, 2005
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 16, 2005	Original application	Approved	None posted

Products

11 strengths and forms


Levothyroxine Sodium0.025MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.05MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.075MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.088MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.1MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.112MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.125MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.15MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.175MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.2MG · tablet;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.3MG · tablet;oral	Levothyroxine Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 31, 2008	Supplement 6Labeling	Approved	None posted
Sep 19, 2006	Supplement 2Labeling	Approved	None posted
Jun 16, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76752
Drugs@FDA: Overview at FDA
Company: Merck KGaA

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