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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 206533

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NDA 206533 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 206533

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Apr 15, 2019	TE:	AP	RLD:	No

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