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Last Updated: January 2, 2025

Details for New Drug Application (NDA): 218023

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NDA 218023 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-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 218023

Tradename:	ACETAZOLAMIDE
Applicant:	Epic Pharma Llc
Ingredient:	acetazolamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 218023

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	May 14, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 14, 2024	TE:	AB	RLD:	No

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