Data updated: Mar 10, 2026
TRETINOIN
TRETINOIN
Approved 1998-06-19
24
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-06-19
- Routes
- TOPICAL, ORAL
- Dosage Forms
- CREAM, CAPSULE, GEL, SOLUTION
Companies
AbbVie GLENMARK PHARMS LTD SUN PHARMA CANADA ENCUBE PADAGIS US Aurobindo Pharma ALEMBIC RISING WOCKHARDT Viatris Teva ZO SKIN HEALTH PH HEALTH ZYDUS LIFESCIENCES
Active Ingredient: TRETINOIN
Website: ↗
TRETINOIN Approval History
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What TRETINOIN Treats
24 FDA approvalsOriginally approved for its first indication in 1998 . Covers 24 distinct patient populations.
- Other (24)
Other
(24 approvals)- • Approved indication (Jun 1998)Letter
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Jan 1999)Label Letter
- • Approved indication (Feb 2000)Letter
- • Approved indication (Jun 2002)
- • Approved indication (Sep 2005)
- • Approved indication (Jun 2007)Letter
- • Approved indication (Mar 2010)
- • Approved indication (Oct 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Jul 2013)Label Letter
- • Approved indication (Aug 2015)
- • Approved indication (Dec 2016)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2023)
- • Approved indication (Apr 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)
- • Approved indication (Mar 2025)
- • Approved indication (Jul 2025) New
- • Approved indication (Aug 2025) New
- • Approved indication (Feb 2026) New
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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.
TRETINOIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.