Glucagon

NDA 201849, held by Fresenius Kabi USA. Glucagon Hydrochloride.

As of Nov 13, 2026, NDA 201849 (Glucagon), held by Fresenius Kabi USA, was first approved by FDA on May 8, 2015, with 8 approved supplements and 0 published complete response letters.

First approved: May 8, 2015
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Limitations of Use: Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 9, 2019	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 8, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
GlucagonEQ 1MG BASE/VIAL · powder;intramuscular, intravenous	Glucagon Hydrochloride	RxReference drug
GlucagonEQ 1MG BASE/VIAL · powder;intramuscular, intravenous, subcutaneous	Glucagon Hydrochloride	RxReference drug

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 16, 2026	Supplement 27Labeling · Standard review	Approved	None posted
Jul 30, 2025	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 14, 2022	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 29, 2021	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 9, 2019	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 1, 2015	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 3, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 3, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
May 8, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter

Identifiers

Application: NDA 201849
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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