Data updated: Jul 17, 2026
ADAPALENE · FOUGERA PHARMS
Dermatology
Approved 1996-05-31
Use For the treatment of acne
Source: FDA Label
11
Indications
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-05-31
- Routes
- TOPICAL
- Dosage Forms
- CREAM, GEL, SOLUTION
Companies
FOUGERA PHARMS GLENMARK PHARMS LTD Teva SUN PHARMA CANADA UNIQUE P AND L WAYLIS THERAP ALEMBIC ENCUBE ETHICALS
Active Ingredient: ADAPALENE
Website: ↗
ADAPALENE Approval History
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
23 FDA actions from 2010 to 2026
Jun 2026 ORIGINAL
Update
Mar 2026 SUPPL
Mfg · Manufacturing (CMC)
Aug 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label
Dec 2023 SUPPL
Label
Jul 2023 SUPPL
Mfg
Apr 2023 SUPPL
Label
Mar 2023 SUPPL
Label
Jan 2022 ORIGINAL
Update
Jun 2020 ORIGINAL
Update
Jul 2019 SUPPL
Label
Jul 2019 SUPPL
Mfg
Jul 2017 SUPPL
Label
Sep 2016 ORIGINAL
Update
Jun 2016 ORIGINAL
Update
Jan 2016 ORIGINAL
Update
Jun 2012 ORIGINAL
Update
Jul 2010 ORIGINAL
Update
What ADAPALENE Treats
11 FDA approvalsOriginally approved for its first indication in 2010 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Jun 2010)Letter
- • Approved indication (Jun 2010)Letter
- • Approved indication (Jul 2010)
- • Approved indication (Jun 2012)
- • Approved indication (Oct 2014)Letter
- • Approved indication (Jan 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Jun 2020)
- • Approved indication (Jan 2022)
- • Approved indication (Jun 2026) New
📋
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01213199 results posted | RD.03.SPR.29088 | Ph 2 | completed | Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars |
| NCT00660985 results posted | RD.06.SPR.18115 | Ph 4 | completed | Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1% |
| NCT03626298 | PapulexPaper1 | Ph 4 | completed | Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia |
| NCT01406080 FOTEN | BR.10.002 | Ph 3 | completed | A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging |
🔬
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.
ADAPALENE FDA Label Details
Indications & Usage
Use For the treatment of acne
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.