Thyrel Trh

As of Nov 13, 2026, NDA 18087 (Thyrel Trh), held by Ferring, was first approved by FDA on Jul 18, 1978, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1978
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 18, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thyrel Trh0.5MG/ML · injectable;injection	Protirelin	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 23, 1994	Supplement 13Labeling · Standard review	Approved	None posted
Jul 21, 1992	Supplement 12Labeling · Standard review	Approved	None posted
Apr 23, 1991	Supplement 11Labeling · Standard review	Approved	None posted
Apr 3, 1991	Supplement 10Labeling · Standard review	Approved	None posted
Jul 1, 1986	Supplement 8Labeling · Standard review	Approved	None posted
Sep 3, 1985	Supplement 7Labeling · Standard review	Approved	None posted
Nov 13, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 28, 1983	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 10, 1981	Supplement 5Labeling · Standard review	Approved	None posted
May 15, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 18, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18087
Drugs@FDA: Overview at FDA
Company: Ferring 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