Glucagon

NDA 12122, held by Lilly. Glucagon Hydrochloride.

As of Nov 13, 2026, NDA 12122 (Glucagon), held by Lilly, was first approved by FDA on Nov 14, 1960, with 30 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1960
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Jun 15, 1981	Supplement 14Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 21, 1980	Supplement 13Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 27, 1979	Supplement 12Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 14, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


GlucagonEQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Glucagon Hydrochloride	DiscontinuedReference drug
GlucagonEQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Glucagon Hydrochloride	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Jun 26, 1998	Supplement 43Manufacturing · Priority review	Approved	None posted
Jan 8, 1998	Supplement 41Manufacturing · Priority review	Approved	None posted
Sep 23, 1997	Supplement 42Manufacturing · Priority review	Approved	None posted
May 12, 1997	Supplement 39Labeling · Priority review	Approved	None posted
Apr 18, 1997	Supplement 40Labeling · Priority review	Approved	None posted
Dec 13, 1996	Supplement 37Manufacturing · Priority review	Approved	None posted
Nov 7, 1996	Supplement 38Manufacturing · Priority review	Approved	None posted
Apr 19, 1996	Supplement 35Manufacturing · Priority review	Approved	None posted
Dec 15, 1995	Supplement 36Labeling · Priority review	Approved	None posted
Apr 28, 1993	Supplement 34Labeling · Priority review	Approved	None posted
Nov 19, 1991	Supplement 33Manufacturing · Priority review	Approved	None posted
Apr 3, 1991	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 11, 1990	Supplement 31Labeling · Priority review	Approved	None posted
Oct 4, 1990	Supplement 30Labeling · Priority review	Approved	None posted
Oct 1, 1990	Supplement 32Labeling · Priority review	Approved	None posted
Dec 2, 1988	Supplement 29Labeling · Priority review	Approved	None posted
Sep 30, 1988	Supplement 28Manufacturing · Priority review	Approved	None posted
Jan 5, 1988	Supplement 27Labeling · Priority review	Approved	None posted
Sep 30, 1986	Supplement 25Labeling · Priority review	Approved	None posted
Dec 13, 1984	Supplement 19Labeling · Priority review	Approved	None posted
Aug 9, 1984	Supplement 18Labeling · Priority review	Approved	None posted
Aug 2, 1984	Supplement 17Manufacturing · Priority review	Approved	None posted
Jul 21, 1983	Supplement 16Labeling · Priority review	Approved	None posted
Oct 9, 1981	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 15, 1981	Supplement 14Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 21, 1980	Supplement 13Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 27, 1979	Supplement 12Efficacy (new indication or use) · Priority review	Approved	None posted
Dec 31, 1975	Supplement 10Manufacturing · Priority review	Approved	None posted
May 20, 1975	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 27, 1975	Supplement 9Manufacturing · Priority review	Approved	None posted
Nov 14, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12122
Drugs@FDA: Overview at FDA
Company: Lilly

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