FDA — authorised 18 December 2003
- Application: NDA021323
- Marketing authorisation holder: ABBVIE
- Indication: Efficacy
- Status: approved
🇺🇸 Lexapro in United States
FDA authorised Lexapro on 18 December 2003
Marketing authorisations
FDA — authorised 12 September 2012
- Application: ANDA202280
- Marketing authorisation holder: JUBILANT CADISTA
- Status: approved
FDA — authorised 7 September 2021
- Application: ANDA079062
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 25 October 2024
- Application: ANDA090939
- Marketing authorisation holder: TORRENT PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Lexapro, an escitalopram oxalate product, for marketing in the United States on 2024-10-25. The approval was granted to TORRENT PHARMS LTD. The application was submitted under the standard expedited pathway.
FDA — authorised 29 August 2025
- Application: NDA219130
- Marketing authorisation holder: ALMATICA
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Lexapro, a medication developed by ALMATICA, for a new dosage form on 29 August 2025. This approval was granted under the standard expedited pathway. The new dosage form is intended to provide an alternative treatment option for patients.
Lexapro 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 Lexapro approved in United States?
Yes. FDA authorised it on 18 December 2003; FDA authorised it on 12 September 2012; FDA authorised it on 7 September 2021.
Who is the marketing authorisation holder for Lexapro in United States?
ABBVIE holds the US marketing authorisation.