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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 040904

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NDA 040904 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 040904

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

Pharmacology for NDA: 040904

Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for 040904

Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics

Suppliers and Packaging for NDA: 040904

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	040904	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-787	23155-787-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (23155-787-01)
ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	040904	ANDA	A-S Medication Solutions	50090-5945	50090-5945-0	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5945-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Dec 10, 2008	TE:	AB	RLD:	No

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