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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205301

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NDA 205301 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, Ascot, Aurobindo Pharma Ltd, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, 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 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 205301

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

Pharmacology for NDA: 205301

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 205301

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 205301

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	205301	ANDA	American Health Packaging	60687-578	60687-578-21	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-578-21) / 1 CAPSULE in 1 BLISTER PACK (60687-578-11)
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	205301	ANDA	Zydus Lifesciences Limited	65841-762	65841-762-01	100 CAPSULE in 1 BOTTLE (65841-762-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jan 16, 2019	TE:	AB	RLD:	No

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