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Data updated: Mar 10, 2026

HYDROCORTISONE AND ACETIC ACID

ACETIC ACID, GLACIAL Corticosteroid Hormone Receptor Agonists
Infectious Disease Approved 1985-03-04
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1985-03-04
Routes
OTIC
Dosage Forms
SOLUTION/DROPS

Companies

COSETTE TARO BAUSCH AND LOMB WOCKHARDT
Active Ingredient: ACETIC ACID, GLACIAL , HYDROCORTISONE

HYDROCORTISONE AND ACETIC ACID Approval History

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What HYDROCORTISONE AND ACETIC ACID Treats

1 indications

HYDROCORTISONE AND ACETIC ACID is approved for 1 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammation
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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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.

HYDROCORTISONE AND ACETIC ACID FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

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Data Sources

FDA Approval: ANDA040609 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.