Data updated: Mar 10, 2026
ACETIC ACID
ACETIC ACID, GLACIAL
Infectious Disease
Approved 1977-05-11
5
Indications
--
Phase 3 Trials
48
Years on Market
Details
- Status
- Prescription
- First Approved
- 1977-05-11
- Routes
- OTIC
- Dosage Forms
- SOLUTION/DROPS
ACETIC ACID Approval History
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What ACETIC ACID Treats
5 FDA approvalsOriginally approved for its first indication in 1977 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (May 1977)
- • Approved indication (Sep 1984)
- • Approved indication (Jul 1996)
- • Approved indication (Feb 2005)
- • Approved indication (Mar 2018)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ACETIC ACID FDA Label Details
ProIndications & Usage
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.