Thyrolar-0.25, Thyrolar-2, Thyrolar-3

NDA 16807, held by Allergan. Liotrix (T4;T3).

As of Nov 13, 2026, NDA 16807 (Thyrolar-0.25, Thyrolar-2, Thyrolar-3), held by Allergan, was first approved by FDA on Nov 21, 1969, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 21, 1969
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Nov 21, 1969	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms

Product	Active ingredient	Marketing
Thyrolar-0.250.0125MG;0.0031MG · tablet;oral	Liotrix (T4;T3)	DiscontinuedReference drug
Thyrolar-20.1MG;0.025MG · tablet;oral	Liotrix (T4;T3)	DiscontinuedReference drug
Thyrolar-30.15MG;0.0375MG · tablet;oral	Liotrix (T4;T3)	DiscontinuedReference drug
Thyrolar-10.05MG;0.0125MG · tablet;oral	Liotrix (T4;T3)	DiscontinuedReference drug
Thyrolar-0.50.025MG;0.0063MG · tablet;oral	Liotrix (T4;T3)	DiscontinuedReference drug
Thyrolar-50.25MG;0.0625MG · tablet;oral	Liotrix (T4;T3)	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 14, 2014	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 13, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 1, 2002	Supplement 25Labeling · Standard review	Approved	Letter
Jun 8, 2001	Supplement 24Manufacturing · Standard review	Approved	None posted
May 17, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
May 16, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 16, 1990	Supplement 21Labeling	Approved	None posted
Mar 6, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 17, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
May 8, 1985	Supplement 18Labeling	Approved	None posted
Dec 14, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 15, 1980	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 12, 1980	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 8, 1980	Supplement 12Labeling	Approved	None posted
Apr 12, 1979	Supplement 11Labeling	Approved	None posted
Jun 26, 1975	Supplement 1Labeling	Approved	None posted
Jun 26, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 26, 1975	Supplement 3Labeling	Approved	None posted
Jun 26, 1975	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 21, 1969	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16807
Drugs@FDA: Overview at FDA
Company: Allergan

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