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 6 May 2011
- Application: ANDA078421
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: approved
FDA — authorised 3 March 2014
- Application: ANDA091272
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA212277
- Marketing authorisation holder: ANNORA PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Effexor for its approved labeling on 2024-03-19. This approval was granted to ANNORA PHARMA through a standard expedited pathway. Effexor is a medication used to treat various conditions, but the specific indications approved by the FDA are not specified in the provided information.
FDA — authorised 23 April 2025
- Application: ANDA204889
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Effexor, an antidepressant medication, for its labeling indication on 2025-04-23. The marketing authorisation holder is MACLEODS PHARMS LTD. The approval was granted 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 Metabolic 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 6 May 2011; FDA authorised it on 3 March 2014.
Who is the marketing authorisation holder for Effexor in United States?
UPJOHN holds the US marketing authorisation.