OXYBUTYNIN · Teva
OXYBUTYNIN is FDA-approved to treat 2 conditions (same as OXYTROL).
Details
- Status
- Prescription
- First Approved
- 2003-02-26
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
OXYBUTYNIN Approval History
What OXYBUTYNIN Treats
2 indicationsOXYBUTYNIN is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urge Urinary Incontinence
Same approved indications as OXYTROL (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03919955 results posted | 2019P000666 R01HL146697 | Ph 2 | completed | A Novel Pharmacological Therapy for Obstructive Sleep Apnea |
| NCT01855256 H²O | RB 12.035 H²O | Ph 3 | completed | Treatment of Hyperhidrosis With Oxybutynin |
| NCT06106529 REDFLASH | REDFLASH2023-004 | Ph 3 | recruiting | REDucing Hot FLASHes in Women Using Endocrine Therapy. |
| NCT06737016 | Tamsulosin & PUV | Ph 3 | recruiting | Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve. |
| NCT01192568 results posted | OG09002 | Ph 4 | completed | Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder |
| NCT03877289 | OxyRCT1 | Ph 4 | completed | Efficacy of Oxybutynin in Paediatric Cystitis |
| NCT01557244 results posted | A0221047 2010-022475-55 | Ph 3 | completed | A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition |
| NCT02240459 | FES-COG 1808 | Ph 2 | completed | A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment |
| NCT02099695 | CRT069 | Ph 3 | withdrawn | Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis |
| NCT02538302 | 92.121.505 | Ph 3 | completed | Minirin Versus Oxybutynin for Nocturnal Enuresis in Children |
| NCT00909181 results posted | 20070060 | Ph 3 | completed | Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence |
| NCT01716624 | R-11-140 17787 | Ph 3 | completed | Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder |
| NCT01126424 SENIOR results posted | 905-EC-008 2008-005966-29 | Ph 4 | completed | A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability |
| NCT01310712 | University of Sao Paulo | Ph 4 | completed | Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 FDA Label Details
Indications & Usage
OXYBUTYNIN is FDA-approved to treat 2 conditions — same approved indications as OXYTROL.
Looking for the branded version?
OXYTROL
Full clinical data, patents, trials, and competitive landscape for oxybutynin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.