TheraRadar
Data updated: May 26, 2026

ACLOVATE (alclometasone dipropionate)

Dermatology Approved 1982-12-14
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
43
Years on Market

Details

Status
Discontinued
First Approved
1982-12-14
Routes
TOPICAL
Dosage Forms
CREAM, OINTMENT

Companies

FOUGERA PHARMS
Active Ingredient: ALCLOMETASONE DIPROPIONATE

ACLOVATE Approval History

1983
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Original
New Indication
New Form
Label Update
20 FDA actions from 1982 to 2011 · 1 indication expansions
Apr 2011 SUPPL
Label · Labeling
FDA Letter Label
Apr 2003 SUPPL
Label · Labeling
FDA Letter Label
Jul 2002 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What ACLOVATE Treats

2 FDA approvals

Originally approved for its first indication in 1982 . Covers 2 distinct patient populations.

  • Other (2)
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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

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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.

ACLOVATE FDA Label Details

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Data Sources

FDA Approval: NDA018707 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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