Details for New Drug Application (NDA): 201849

NDA 201849 describes GLUCAGON, which is a drug marketed by Amphastar Pharms Inc, Lilly, and Fresenius Kabi Usa, and is included in four NDAs. It is available from four suppliers. Additional details are available on the GLUCAGON profile page.

The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.

Summary for 201849

Tradename:	GLUCAGON
Applicant:	Fresenius Kabi Usa
Ingredient:	glucagon hydrochloride
Patents:	0

Pharmacology for NDA: 201849

Physiological Effect

Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

Suppliers and Packaging for NDA: 201849

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	201849	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1498	51662-1498-1	1 KIT in 1 KIT (51662-1498-1) * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 SYRINGE, GLASS
GLUCAGON	glucagon hydrochloride	POWDER;INTRAMUSCULAR, INTRAVENOUS	201849	NDA	Fresenius Kabi USA, LLC	63323-582	63323-582-82	1 KIT in 1 KIT (63323-582-82) * 1 mL in 1 VIAL, SINGLE-DOSE (63323-583-13) * 1 mL in 1 SYRINGE, GLASS (63323-185-82)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 1MG BASE/VIAL
Approval Date:	May 8, 2015	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	EQ 1MG BASE/VIAL
Approval Date:	Sep 19, 2019	TE:		RLD:	Yes

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