Data updated: May 26, 2026
CONDYLOX (podofilox)
Dermatology
Approved 1990-12-13
2
Indications
--
Phase 3 Trials
1
Priority Reviews
35
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1990-12-13
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION, GEL
CONDYLOX Approval History
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 1990 to 2015
Oct 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Sep 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Jan 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
May 2013 SUPPL Priority
Mfg
Jun 1995 SUPPL Priority
Mfg
May 1995 SUPPL Priority
Mfg
Jan 1994 SUPPL Priority
Mfg
Nov 1993 SUPPL Priority
Mfg
Aug 1993 SUPPL Priority
Mfg
Nov 1991 SUPPL Priority
Mfg
Dec 1990 ORIGINAL Priority
New Form
What CONDYLOX Treats
2 FDA approvalsOriginally approved for its first indication in 1990 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 1990) Priority
- • Approved indication (Mar 1997)Label
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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.
CONDYLOX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.