Cytomel

NDA 10379, held by King Pharms. Liothyronine Sodium.

As of Nov 13, 2026, NDA 10379 (Cytomel), held by King Pharms, was first approved by FDA on May 8, 1956, with 16 approved supplements and 0 published complete response letters.

First approved: May 8, 1956
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
May 8, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


CytomelEQ 0.005MG BASE · tablet;oral	Liothyronine Sodium	RxReference drug
CytomelEQ 0.025MG BASE · tablet;oral	Liothyronine Sodium	RxReference drug
CytomelEQ 0.05MG BASE · tablet;oral	Liothyronine Sodium	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 21, 2020	Supplement 57Labeling · Standard review	Approved	Letter
Dec 21, 2018	Supplement 54Labeling · Standard review	Approved	Letter Label
May 17, 2002	Supplement 47Labeling · Standard review	Approved	Letter Label
Feb 27, 2002	Supplement 46Manufacturing · Priority review	Approved	None posted
Sep 13, 2001	Supplement 45Labeling · Standard review	Approved	Letter
Apr 14, 2001	Supplement 44Manufacturing · Priority review	Approved	None posted
Nov 16, 2000	Supplement 42Manufacturing · Priority review	Approved	None posted
Jul 18, 2000	Supplement 43Manufacturing · Priority review	Approved	None posted
Mar 17, 1995	Supplement 40Labeling · Standard review	Approved	None posted
Jun 2, 1994	Supplement 41Manufacturing · Priority review	Approved	None posted
Mar 28, 1994	Supplement 39Labeling	Approved	None posted
Aug 6, 1990	Supplement 38Manufacturing · Priority review	Approved	None posted
Feb 19, 1986	Supplement 37Labeling	Approved	None posted
Mar 7, 1984	Supplement 36Labeling	Approved	None posted
Mar 7, 1984	Supplement 34Labeling	Approved	None posted
Jun 16, 1975	Supplement 14Labeling	Approved	None posted
May 8, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10379
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