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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 219775

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NDA 219775 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 are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.

Summary for 219775

Tradename:	ACETAZOLAMIDE SODIUM
Applicant:	Gland
Ingredient:	acetazolamide sodium
Patents:	0

Pharmacology for NDA: 219775

Mechanism of Action	Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 219775

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	219775	ANDA	Sagent Pharmaceuticals	25021-839	25021-839-20	1 VIAL in 1 CARTON (25021-839-20) / 5 mL in 1 VIAL
ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	219775	ANDA	Gland Pharma Limited	68083-661	68083-661-01	1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 17, 2025	TE:	AP	RLD:	No

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