FDA — authorised 14 November 1988
- Application: ANDA071655
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 OXYBUTYNIN CHLORIDE in United States
FDA authorised OXYBUTYNIN CHLORIDE on 14 November 1988 · 5,532 US adverse-event reports
Marketing authorisations
FDA — authorised 29 March 1996
- Application: ANDA074520
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 July 1996
- Application: ANDA074625
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 1997
- Application: ANDA074868
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 15 October 1997
- Application: ANDA074997
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 October 1997
- Application: ANDA075079
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 1999
- Application: ANDA075039
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 December 2004
- Application: ANDA076682
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 9 November 2006
- Application: ANDA076644
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 November 2006
- Application: ANDA076745
- Marketing authorisation holder: IMPAX PHARMS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 May 2007
- Application: ANDA078293
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: Oxybutynin Chloride
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 February 2009
- Application: ANDA078503
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 November 2015
- Application: ANDA204010
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 February 2016
- Application: ANDA207138
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 May 2016
- Application: ANDA206121
- Marketing authorisation holder: UNIQUE
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 June 2017
- Application: ANDA202332
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 October 2017
- Application: ANDA209823
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2017
- Application: ANDA209025
- Marketing authorisation holder: RISING
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA209335
- Marketing authorisation holder: ABHAI LLC
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2018
- Application: ANDA207329
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 6 September 2018
- Application: ANDA210125
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 2019
- Application: ANDA211062
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2019
- Application: ANDA211655
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 May 2019
- Application: ANDA211682
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2019
- Application: ANDA210717
- Marketing authorisation holder: BIONPHARMA
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2020
- Application: ANDA212798
- Marketing authorisation holder: LEADING
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA214415
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 July 2022
- Application: ANDA213550
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072296
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070746
- Marketing authorisation holder: USL PHARMA
- Local brand name: OXYBUTYNIN CHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,532
Most-reported reactions
- Drug Ineffective — 734 reports (13.27%)
- Fatigue — 721 reports (13.03%)
- Fall — 609 reports (11.01%)
- Nausea — 596 reports (10.77%)
- Headache — 555 reports (10.03%)
- Diarrhoea — 507 reports (9.16%)
- Pain — 482 reports (8.71%)
- Urinary Tract Infection — 475 reports (8.59%)
- Dizziness — 436 reports (7.88%)
- Constipation — 417 reports (7.54%)
OXYBUTYNIN CHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is OXYBUTYNIN CHLORIDE approved in United States?
Yes. FDA authorised it on 14 November 1988; FDA authorised it on 29 March 1996; FDA authorised it on 31 July 1996.
Who is the marketing authorisation holder for OXYBUTYNIN CHLORIDE in United States?
TEVA PHARMS USA holds the US marketing authorisation.