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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210423

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NDA 210423 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 210423

Tradename:	ACETAZOLAMIDE
Applicant:	Alembic
Ingredient:	acetazolamide
Patents:	0

Pharmacology for NDA: 210423

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 210423

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 210423

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	210423	ANDA	Alembic Pharmaceuticals Limited	46708-349	46708-349-31	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-31)
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	210423	ANDA	Alembic Pharmaceuticals Limited	46708-349	46708-349-91	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-349-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Feb 19, 2019	TE:	AB	RLD:	No

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