You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

Details for New Drug Application (NDA): 040904

✉ Email this page to a colleague

« Back to Dashboard

NDA 040904 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.