Glucagen

NDA 20918, held by Novo Nordisk. Glucagon Hydrochloride.

As of Nov 13, 2026, NDA 20918 (Glucagen), held by Novo Nordisk, was first approved by FDA on Jun 22, 1998, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 22, 1998
Review: Priority
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jun 22, 1998	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

2 strengths and forms


GlucagenEQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intramuscular, intravenous	Glucagon Hydrochloride	DiscontinuedReference drug
GlucagenEQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intramuscular, intravenous, subcutaneous	Glucagon Hydrochloride	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Jul 20, 2021	Supplement 56Labeling · Standard review	Approved	Label Letter
Mar 11, 2021	Supplement 54Labeling · Standard review	Approved	Letter Label
Sep 3, 2020	Supplement 53Labeling · Standard review	Approved	Letter
Jul 6, 2018	Supplement 52Labeling	Approved	Label
Apr 18, 2018	Supplement 49Labeling · Standard review	Approved	Letter Label
Feb 11, 2016	Supplement 47Manufacturing · Priority review	Approved	None posted
Dec 10, 2015	Supplement 43Labeling · Standard review	Approved	Letter Label
Oct 8, 2015	Supplement 44Manufacturing · Priority review	Approved	None posted
Mar 14, 2014	Supplement 42Labeling · Standard review	Approved	Letter
Apr 26, 2013	Supplement 39Manufacturing · Priority review	Approved	None posted
Apr 26, 2013	Supplement 40Labeling · Standard review	Approved	Letter
Jan 16, 2013	Supplement 38Manufacturing · Priority review	Approved	None posted
Dec 29, 2011	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 15, 2010	Supplement 30Labeling	Approved	Label Letter
Jun 28, 2007	Supplement 23Manufacturing	Approved	None posted
Nov 14, 2005	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 23, 2004	Supplement 12Manufacturing · Priority review	Approved	Letter Label
Mar 1, 2004	Supplement 8Labeling · Standard review	Approved	Review Label Letter
Aug 5, 2002	Supplement 5Manufacturing · Priority review	Approved	None posted
Jul 11, 2002	Supplement 3Labeling · Standard review	Approved	Review Letter
Apr 1, 2002	Supplement 4Manufacturing · Priority review	Approved	None posted
Aug 18, 2000	Supplement 2Labeling · Standard review	Approved	None posted
May 30, 2000	Supplement 1Labeling · Standard review	Approved	None posted
Jun 22, 1998	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 20918
Drugs@FDA: Overview at FDA
Company: Novo Nordisk

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