FDA — authorised 1 August 2007
- Application: NDA020699
- Marketing authorisation holder: UPJOHN
- Indication: Labeling
- Status: approved
🇺🇸 Effexor in United States
FDA authorised Effexor on 1 August 2007
Marketing authorisations
FDA — authorised 3 March 2014
- Application: ANDA091272
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 29 June 2022
- Application: NDA215429
- Marketing authorisation holder: ALMATICA
- Indication: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
- Status: approved
FDA — authorised 12 August 2024
- Application: ANDA214127
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
ALKEM LABS LTD received marketing authorisation from the FDA for Effexor on 12 August 2024. The application number for this approval is ANDA214127. Effexor is approved for use in the United States, but the local brand name is not reported.
FDA — authorised 23 April 2025
- Application: ANDA204889
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Effexor for its labelled indication on 2025-04-23. The marketing authorisation holder is MACLEODS PHARMS LTD. Effexor was approved through the standard expedited pathway.
Effexor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Effexor approved in United States?
Yes. FDA authorised it on 1 August 2007; FDA authorised it on 3 March 2014; FDA authorised it on 29 June 2022.
Who is the marketing authorisation holder for Effexor in United States?
UPJOHN holds the US marketing authorisation.