Geref

NDA 19863, held by Emd Serono. Sermorelin Acetate.

As of Nov 14, 2026, NDA 19863 (Geref), held by Emd Serono, was first approved by FDA on Dec 28, 1990, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1990
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 28, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GerefEQ 0.05MG BASE/AMP Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Sermorelin Acetate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Oct 2, 2001	Supplement 6Labeling · Standard review	Approved	None posted
Apr 3, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 27, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Aug 26, 1991	Supplement 1Manufacturing · Standard review	Approved	Review
May 28, 1991	Supplement 2Manufacturing · Standard review	Approved	Review
Dec 28, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19863
Drugs@FDA: Overview at FDA
Company: EMD Serono, Inc.

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