FDA — authorised 13 March 2015
- Application: ANDA091190
- Marketing authorisation holder: PH HEALTH
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 DARIFENACIN HYDROBROMIDE in United States
FDA authorised DARIFENACIN HYDROBROMIDE on 13 March 2015 · 744 US adverse-event reports
Marketing authorisations
FDA — authorised 1 September 2016
- Application: ANDA207664
- Marketing authorisation holder: CIPLA
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 September 2016
- Application: ANDA206743
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 October 2016
- Application: ANDA205550
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 November 2016
- Application: ANDA205209
- Marketing authorisation holder: TORRENT
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA207681
- Marketing authorisation holder: ALEMBIC
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 January 2020
- Application: ANDA211045
- Marketing authorisation holder: PURACAP LABS BLU
- Local brand name: DARIFENACIN HYDROBROMIDE
- Indication: TABLET, EXTENDED RELEASE — 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: 744
Most-reported reactions
- Drug Ineffective — 115 reports (15.46%)
- Herpes Zoster — 77 reports (10.35%)
- Synovitis — 76 reports (10.22%)
- Joint Swelling — 71 reports (9.54%)
- Arthralgia — 70 reports (9.41%)
- Fibromyalgia — 70 reports (9.41%)
- Peripheral Swelling — 68 reports (9.14%)
- Anaemia — 67 reports (9.01%)
- Leukopenia — 66 reports (8.87%)
- Blood Cholesterol Increased — 64 reports (8.6%)
DARIFENACIN HYDROBROMIDE 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 DARIFENACIN HYDROBROMIDE approved in United States?
Yes. FDA authorised it on 13 March 2015; FDA authorised it on 1 September 2016; FDA authorised it on 19 September 2016.
Who is the marketing authorisation holder for DARIFENACIN HYDROBROMIDE in United States?
PH HEALTH holds the US marketing authorisation.