FDA — authorised 29 June 2015
- Application: ANDA204028
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 DESVENLAFAXINE SUCCINATE in United States
FDA authorised DESVENLAFAXINE SUCCINATE on 29 June 2015 · 2,092 US adverse-event reports
Marketing authorisations
FDA — authorised 29 June 2015
- Application: ANDA204172
- Marketing authorisation holder: LUPIN
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA204003
- Marketing authorisation holder: ALEMBIC
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA204095
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 February 2016
- Application: ANDA204083
- Marketing authorisation holder: HIKMA
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 July 2016
- Application: ANDA204065
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 October 2017
- Application: ANDA204020
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 October 2018
- Application: ANDA210014
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 May 2019
- Application: ANDA204805
- Marketing authorisation holder: PLATINUM
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 January 2025
- Application: ANDA211427
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 March 2026
- Application: ANDA220460
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: DESVENLAFAXINE SUCCINATE
- 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: 2,092
Most-reported reactions
- Drug Ineffective — 796 reports (38.05%)
- Headache — 179 reports (8.56%)
- Nausea — 177 reports (8.46%)
- Anxiety — 159 reports (7.6%)
- Off Label Use — 158 reports (7.55%)
- Fatigue — 131 reports (6.26%)
- Depression — 127 reports (6.07%)
- Dizziness — 125 reports (5.98%)
- Feeling Abnormal — 123 reports (5.88%)
- Malaise — 117 reports (5.59%)
DESVENLAFAXINE SUCCINATE 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 DESVENLAFAXINE SUCCINATE approved in United States?
Yes. FDA authorised it on 29 June 2015; FDA authorised it on 29 June 2015; FDA authorised it on 29 June 2015.
Who is the marketing authorisation holder for DESVENLAFAXINE SUCCINATE in United States?
RUBICON RESEARCH holds the US marketing authorisation.