What is CORTEF ACETATE used for?

CORTEF ACETATE is an FDA-approved medication. See full prescribing information for approved uses.

Is CORTEF ACETATE FDA approved?

Yes, CORTEF ACETATE is FDA approved (first approved 1953-07-28) and manufactured by PHARMACIA AND UPJOHN.

Who makes CORTEF ACETATE?

CORTEF ACETATE is manufactured by PHARMACIA AND UPJOHN.

Data updated: Mar 10, 2026

CORTEF ACETATE

HYDROCORTISONE ACETATE

Approved 1953-07-28

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Indication

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1953-07-28
Routes: TOPICAL, INJECTION
Dosage Forms: OINTMENT, INJECTABLE

Companies

PHARMACIA AND UPJOHN

Active Ingredient: HYDROCORTISONE ACETATE

CORTEF ACETATE Approval History

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What CORTEF ACETATE Treats

1 FDA approvals

Originally approved for its first indication in 1953 .

Other (1)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CORTEF ACETATE FDA Label Details

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Data Sources

FDA Approval: NDA008917 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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