Data updated: Mar 10, 2026
FLUOCINONIDE
FLUOCINONIDE Corticosteroid Hormone Receptor Agonists
Approved 1973-05-15
34
Indications
--
Phase 3 Trials
52
Years on Market
Details
- Status
- Prescription
- First Approved
- 1973-05-15
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION, OINTMENT, CREAM, GEL
Companies
MACLEODS PHARMS LTD ENCUBE ETHICALS XIROMED SUN PHARMA CANADA FOUGERA PHARMS INC Teva COSETTE PAI HOLDINGS PHARM AMNEAL GLENMARK PHARMS LTD CHARTWELL RX QUAGEN PERRIGO NEW YORK SCIEGEN PHARMS ZYDUS PHARMS PADAGIS US PADAGIS ISRAEL ZYDUS LIFESCIENCES ENCUBE ALVOGEN NOVEL LABS INC FOUGERA PHARMS
Active Ingredient: FLUOCINONIDE
Website: ↗
FLUOCINONIDE Approval History
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What FLUOCINONIDE Treats
34 FDA approvalsOriginally approved for its first indication in 1973 . Covers 34 distinct patient populations.
- Other (34)
Other
(34 approvals)- • Approved indication (May 1973)
- • Approved indication (Jun 1984)
- • Approved indication (Jun 1987)
- • Approved indication (Dec 1988)
- • Approved indication (Feb 1989)
- • Approved indication (Feb 1989)
- • Approved indication (Aug 1989)
- • Approved indication (Sep 1990)
- • Approved indication (Dec 1991)
- • Approved indication (Feb 1992)
- • Approved indication (Oct 1994)
- • Approved indication (Dec 1994)
- • Approved indication (Feb 1995)
- • Approved indication (Dec 1996)
- • Approved indication (Jul 1997)
- • Approved indication (Aug 1997)
- • Approved indication (Jun 1999)Letter
- • Approved indication (Jan 2014)
- • Approved indication (Jul 2014)Letter
- • Approved indication (Jul 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Apr 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Apr 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Feb 2025)
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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.
FLUOCINONIDE FDA Label Details
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Data Sources
FDA Approval: ANDA209283 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.