Supprelin

NDA 19836, held by Shire. Histrelin Acetate.

As of Nov 13, 2026, NDA 19836 (Supprelin), held by Shire, was first approved by FDA on Dec 24, 1991, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1991
Review: Priority
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 24, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


SupprelinEQ 0.2MG BASE/ML · injectable;injection	Histrelin Acetate	Discontinued
SupprelinEQ 0.5MG BASE/ML · injectable;injection	Histrelin Acetate	Discontinued
SupprelinEQ 1MG BASE/ML · injectable;injection	Histrelin Acetate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 23, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
Oct 17, 1997	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 11, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 24, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19836
Drugs@FDA: Overview at FDA
Company: Shire

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