Acetazolamide

Sold as Diamox. Every FDA application for this active ingredient: 2 branded and 31 generic.

As of Nov 13, 2026, FDA lists 33 applications for Acetazolamide (sold as Diamox), first approved Jul 27, 1953, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 27, 1953
Applications: 33
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $15.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Acetazolamide	Part D	$11.0M	+3%	112,750
Acetazolamide ER	Part D	$4.1M	-12%	36,729
Acetazolamide Sodium	Part B	$0K	-100%	0

Clinical Trials

43 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Natriuresis With Acetazolamide or SGLT2 Inhibitors Added to Intravenous Loop Diuretics in Decompensated Heart FailureHeart Failure, Acute Decompensated Heart Failure (ADHF) · Universidade do Porto	Phase 4	Active, not recruiting	Nov 9, 2026
Adding Acetazolamide on Top of SGLT2 Inhibition in Persons With Type 2 DiabetesT2D · University Health Network, Toronto	Phase 2	Not yet recruiting	Oct 29, 2026
ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.Heart Failure · University Hospital, Montpellier	Phase 3	Not yet recruiting	Jul 30, 2026
Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary ManagementIdiopathic Intracranial Hypertension · Sohag University	Not applicable	Active, not recruiting	Jul 16, 2026
DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.Obstructive Sleep Apnea (OSA) · Incannex Healthcare Ltd	Phase 2	Recruiting	Jun 9, 2026
TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart FailureAcute Heart Failure (AHF) · Lucrecia Maria Burgos	Phase 4	Not yet recruiting	May 18, 2026
The Role of Acetazolamide in Mitigating Inflammation and Innate Immune Activation at High AltitudeHypoxemia, Acute Mountain Sickness (AMS) · University of California, Riverside	Early phase 1	Active, not recruiting	Apr 8, 2026
Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging StudyAlzheimer Dementia (AD), Diabete Type 2 · Copenhagen University Hospital, Rigshospitalet	—	Recruiting	Mar 19, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 27, 1953	DiamoxNDA 8943 · New molecular entity	Teva Branded Pharm	37	Discontinued
Jan 25, 1962	DiamoxNDA 12945 · New formulation or manufacturer	Teva Branded Pharm	9	Discontinued
Jul 18, 1974	AcetazolamideANDA 83320	Alra	0	Discontinued
Mar 31, 1978	AcetazolamideANDA 84840	Chartwell Molecular	13	Marketed
Feb 5, 1982	AcetazolamideANDA 87654	Vangard	1	Discontinued
Oct 22, 1985	AcetazolamideANDA 88882	Heritage Pharma	7	Discontinued
Jun 22, 1988	AcetazolamideANDA 89753	Sun Pharm Industries	10	Discontinued
May 28, 1997	AcetazolamideANDA 40195	Taro	1	Marketed
Dec 10, 2008	AcetazolamideANDA 40904	Heritage Pharma	2	Marketed
Jul 14, 2011	AcetazolamideANDA 90779	Indicus Pharma	2	Marketed
Mar 29, 2016	AcetazolamideANDA 204691	Mpp Pharma	2	Marketed
Sep 30, 2016	AcetazolamideANDA 203434	Novast Labs	1	Marketed
Oct 27, 2016	AcetazolamideANDA 205530	Heritage Pharma	2	Marketed
Nov 20, 2017	AcetazolamideANDA 209734	Strides Pharma	3	Marketed
Oct 18, 2018	AcetazolamideANDA 207659	Accord Hlthcare	3	Marketed
Jan 16, 2019	AcetazolamideANDA 205301	Cadila	2	Marketed
Feb 19, 2019	AcetazolamideANDA 210423	Alembic	2	Marketed
Jun 18, 2019	AcetazolamideANDA 203917	Rising	0	Discontinued
Oct 17, 2019	AcetazolamideANDA 210588	Novitium Pharma	3	Marketed
Oct 18, 2019	AcetazolamideANDA 211556	Adaptis	2	Marketed
Apr 30, 2020	AcetazolamideANDA 207503	Breckenridge	0	Discontinued
Oct 1, 2020	AcetazolamideANDA 207401	Micro Labs Ltd India	2	Marketed
Oct 7, 2020	AcetazolamideANDA 214282	Mankind Pharma	4	Marketed
Feb 22, 2021	AcetazolamideANDA 211372	Somerset Theraps LLC	1	Marketed
Aug 19, 2021	AcetazolamideANDA 215101	Rubicon Research	0	Marketed
Apr 4, 2023	AcetazolamideANDA 211069	Zydus Lifesciences	1	Marketed
May 9, 2023	AcetazolamideANDA 217197	Ne Rx Pharma	1	Marketed
Sep 11, 2023	AcetazolamideANDA 211151	Ajanta Pharma Ltd	2	Discontinued
Jan 26, 2024	AcetazolamideANDA 213706	Torrent	0	Discontinued
May 14, 2024	AcetazolamideANDA 218023	Epic Pharma LLC	1	Marketed
May 30, 2025	AcetazolamideANDA 212089	Aurobindo Pharma Ltd	1	Marketed
—	AcetazolamideANDA 84498	Watson Labs	0	Discontinued
—	AcetazolamideANDA 87686	Ascot	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA