Data updated: Mar 10, 2026
OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE
Approved 1988-11-14
30
Indications
--
Phase 3 Trials
37
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-11-14
- Routes
- ORAL, TRANSDERMAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, GEL, SYRUP
Companies
IMPAX PHARMS Viatris OSMOTICA PHARM US AJANTA PHARMA LTD UNIQUE ABHAI LLC STRIDES PHARMA INTL ZYDUS PHARMS NOVITIUM PHARMA NOVAST LABS CHARTWELL RX RUBICON RESEARCH Teva AIPING PHARM INC PHARMOBEDIENT CNSLTG REGCON HOLDINGS PHARM ASSOC PHARMOBEDIENT STRIDES PHARMA LEADING BIONPHARMA QUANTUM PHARMICS HIBROW HLTHCARE AVET LIFESCIENCES WATSON LABS LANNETT CO INC ACCORD HLTHCARE RISING TP ANDA HOLDINGS AMNEAL PHARMS USL PHARMA
Active Ingredient: OXYBUTYNIN CHLORIDE
Website: ↗
OXYBUTYNIN CHLORIDE Approval History
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What OXYBUTYNIN CHLORIDE Treats
30 FDA approvalsOriginally approved for its first indication in 1988 . Covers 30 distinct patient populations.
- Other (30)
Other
(30 approvals)- • Approved indication (Nov 1988)
- • Approved indication (Mar 1996)
- • Approved indication (Jul 1996)
- • Approved indication (Feb 1997)
- • Approved indication (Oct 1997)
- • Approved indication (Oct 1997)
- • Approved indication (Dec 1998)Letter
- • Approved indication (Jan 1999)
- • Approved indication (Dec 2004)
- • Approved indication (Nov 2006)Letter
- • Approved indication (May 2007)
- • Approved indication (Feb 2009)
- • Approved indication (Nov 2015)
- • Approved indication (Feb 2016)
- • Approved indication (May 2016)
- • Approved indication (Jun 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Dec 2017)
- • Approved indication (May 2018)Letter
- • Approved indication (Sep 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)
- • Approved indication (May 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Dec 2019)
- • Approved indication (Apr 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jul 2022)
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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.
OXYBUTYNIN CHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.