Last Updated: September 24, 2026

Details for New Drug Application (NDA): 040784

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NDA 040784 describes ACETAZOLAMIDE SODIUM, which is a drug marketed by Avet Lifesciences, Gland, Hikma, Hospira, Mylan Asi, Ph Health, Xgen Pharms, and Zydus Pharms, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the ACETAZOLAMIDE SODIUM profile page.

The generic ingredient in ACETAZOLAMIDE SODIUM is acetazolamide sodium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.

Summary for 040784

Tradename:	ACETAZOLAMIDE SODIUM
Applicant:	Xgen Pharms
Ingredient:	acetazolamide sodium
Patents:	0

Pharmacology for NDA: 040784

Mechanism of Action	Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 040784

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	040784	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0190	39822-0190-1	1 VIAL, GLASS in 1 CARTON (39822-0190-1) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Dec 10, 2008	TE:	AP	RLD:	No

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