FDA — authorised 1 August 2007
- Application: NDA020699
- Marketing authorisation holder: UPJOHN
- Indication: Labeling
- Status: approved
🇺🇸 VENLAFAXINE in United States
FDA authorised VENLAFAXINE 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
The FDA approved VENLAFAXINE for marketing by ALKEM LABS LTD on 12 August 2024. The application number for this approval is ANDA214127. This approval was granted through the standard expedited pathway. The approved indication for VENLAFAXINE is listed in the labelling.
FDA — authorised 23 April 2025
- Application: ANDA204889
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
VENLAFAXINE 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 VENLAFAXINE 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 VENLAFAXINE in United States?
UPJOHN holds the US marketing authorisation.