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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212089

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NDA 212089 describes ACETAZOLAMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Mpp Pharma, Novast Labs, Rising, Ajanta Pharma Ltd, Alra, Appco, Ascot, Aurobindo Pharma Ltd, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon Research, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Gland, Hikma, Hospira, Mylan Asi, Ph Health, Xgen Pharms, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from thirty-four suppliers. Additional details are available on the ACETAZOLAMIDE profile page.

The generic ingredient in ACETAZOLAMIDE 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 212089

Tradename:	ACETAZOLAMIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	acetazolamide
Patents:	0

Pharmacology for NDA: 212089

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 212089

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 212089

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	212089	ANDA	Aurobindo Pharma Limited	59651-905	59651-905-01	100 TABLET in 1 BOTTLE (59651-905-01)
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	212089	ANDA	Aurobindo Pharma Limited	59651-906	59651-906-01	100 TABLET in 1 BOTTLE (59651-906-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	May 30, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 30, 2025	TE:	AB	RLD:	No

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