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Last Updated: April 5, 2025

Details for New Drug Application (NDA): 203434

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NDA 203434 describes ACETAZOLAMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Nostrum Labs Inc, Novast Labs, Rising, Ajanta Pharma Ltd, Alra, Appco, Ascot, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from thirty-three 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 203434

Tradename:	ACETAZOLAMIDE
Applicant:	Novast Labs
Ingredient:	acetazolamide
Patents:	0

Pharmacology for NDA: 203434

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 203434

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 203434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	203434	ANDA	Ingenus Pharmaceuticals, LLC	50742-233	50742-233-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-233-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Sep 30, 2016	TE:	AB	RLD:	No

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