Data updated: Mar 10, 2026
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE
Approved 1982-04-27
29
Indications
--
Phase 3 Trials
43
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1982-04-27
- Routes
- TOPICAL, OTIC
- Dosage Forms
- SOLUTION, OINTMENT, OIL, CREAM, OIL/DROPS
Companies
ALPHARMA US PHARMS PHARMAFAIR COSETTE AMNEAL ENCUBE ETHICALS SUN PHARMA CANADA PADAGIS ISRAEL NOVEL LABS INC Teva FOUGERA PHARMS INC RISING PAI HOLDINGS PHARM USL PHARMA Lupin QUAGEN SCIEGEN PHARMS BAUSCH AND LOMB PERRIGO NEW YORK INVATECH PHARMADERM ALLIED TP ANDA HOLDINGS GLENMARK PHARMS LTD CHARTWELL RX
Active Ingredient: FLUOCINOLONE ACETONIDE
Website: ↗
FLUOCINOLONE ACETONIDE Approval History
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What FLUOCINOLONE ACETONIDE Treats
29 FDA approvalsOriginally approved for its first indication in 1982 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Apr 1982)
- • Approved indication (Jun 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Aug 1984)
- • Approved indication (Feb 1985)
- • Approved indication (Mar 1985)
- • Approved indication (Sep 1985)
- • Approved indication (Jul 1988)
- • Approved indication (Dec 1993)
- • Approved indication (Sep 1994)
- • Approved indication (Oct 1994)
- • Approved indication (Oct 2011)
- • Approved indication (Aug 2013)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Sep 2015)Letter
- • Approved indication (Apr 2016)Letter
- • Approved indication (May 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Jul 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Jul 2023)
- • Approved indication (Aug 2023)
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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.
FLUOCINOLONE ACETONIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.