Last Updated: November 8, 2026

Details for New Drug Application (NDA): 214282

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NDA 214282 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, Adaptis, Ajanta Pharma Ltd, Alra, Ascot, Aurobindo Pharma Ltd, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon Research, Somerset Theraps Llc, 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-three suppliers. Additional details are available on the ACETAZOLAMIDE profile page.

The generic ingredient in ACETAZOLAMIDE is acetazolamide sodium. There are two 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 214282

Tradename:	ACETAZOLAMIDE
Applicant:	Mankind Pharma
Ingredient:	acetazolamide
Patents:	0

Pharmacology for NDA: 214282

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 214282

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 214282

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	214282	ANDA	Bryant Ranch Prepack	63629-1194	63629-1194-1	100 TABLET in 1 BOTTLE (63629-1194-1)
ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	214282	ANDA	Bryant Ranch Prepack	63629-1195	63629-1195-1	100 TABLET in 1 BOTTLE (63629-1195-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Oct 7, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 7, 2020	TE:	AB	RLD:	No

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