Levothyroxine Sodium

ANDA 211369, held by Ani Pharms. Levothyroxine Sodium.

As of Nov 15, 2026, ANDA 211369 (Levothyroxine Sodium), held by Ani Pharms, was first approved by FDA on Oct 28, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 28, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 28, 2020	Original application	Approved	Letter

Products

6 strengths and forms


Levothyroxine Sodium0.075MG · capsule;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.15MG · capsule;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.112MG · capsule;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.2MG · capsule;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.137MG · capsule;oral	Levothyroxine Sodium	Discontinued
Levothyroxine Sodium0.175MG · capsule;oral	Levothyroxine Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 2, 2023	Supplement 5Manufacturing	Approved	None posted
Oct 28, 2020	Original application	Approved	Letter

Identifiers

Application: ANDA 211369
Drugs@FDA: Overview at FDA
Company: ANI 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