ACETAZOLAMIDE
Details
- Status
- Prescription
- First Approved
- 1974-07-18
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE
Companies
ACETAZOLAMIDE Approval History
What ACETAZOLAMIDE Treats
5 indicationsACETAZOLAMIDE is approved for 5 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Epilepsy
- Glaucoma
- Acute Mountain Sickness
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACETAZOLAMIDE FDA Label Details
ProIndications & Usage
For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.