Lutrepulse Kit

NDA 19687, held by Ferring. Gonadorelin Acetate.

As of Nov 13, 2026, NDA 19687 (Lutrepulse Kit), held by Ferring, was first approved by FDA on Oct 10, 1989, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1989
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 10, 1989	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

2 strengths and forms


Lutrepulse Kit0.8MG/VIAL · injectable;injection	Gonadorelin Acetate	Discontinued
Lutrepulse Kit3.2MG/VIAL · injectable;injection	Gonadorelin Acetate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Dec 2, 1993	Supplement 13Labeling · Standard review	Approved	None posted
Apr 5, 1993	Supplement 12Labeling · Standard review	Approved	None posted
Aug 21, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 13, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 9, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 7, 1991	Supplement 8Labeling	Approved	None posted
Jun 10, 1991	Supplement 2Labeling	Approved	None posted
Jul 18, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 27, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 10, 1989	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19687
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