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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204468

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NDA 204468 describes GLUCAGON, which is a drug marketed by Amphastar Pharms Inc, Cipla, Lilly, Lupin Ltd, Mylan Labs Ltd, and Fresenius Kabi Usa, and is included in seven NDAs. It is available from eight 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. Two suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.

Summary for 204468

Tradename:	GLUCAGON
Applicant:	Mylan Labs Ltd
Ingredient:	glucagon
Patents:	0

Medical Subject Heading (MeSH) Categories for 204468

Gastrointestinal Agents
Hormones

Suppliers and Packaging for NDA: 204468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLUCAGON	glucagon	INJECTABLE;INJECTION	204468	ANDA	Mylan Pharmaceuticals Inc.	0378-8067	0378-8067-90	1 KIT in 1 KIT (0378-8067-90) * 1 mL in 1 VIAL (0378-8065-32) * 1 mL in 1 SYRINGE (0378-8066-32)
GLUCAGON	glucagon	INJECTABLE;INJECTION	204468	ANDA	Sportpharm, Inc. dba Sportpharm	85766-065	85766-065-01	1 KIT in 1 KIT (85766-065-01) * 1 mL in 1 VIAL (0378-8065-32) * 1 mL in 1 SYRINGE (0378-8066-32)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/VIAL
Approval Date:	Dec 12, 2024	TE:	AP	RLD:	No

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