FDA — authorised 17 November 2015
- Application: ANDA091689
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Indication: Labeling
- Status: approved
🇺🇸 Exelon in United States
FDA authorised Exelon on 17 November 2015
Marketing authorisations
FDA — authorised 2 November 2016
- Application: NDA022083
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2017
- Application: ANDA203844
- Marketing authorisation holder: CADILA PHARMS LTD
- Status: approved
FDA — authorised 4 April 2019
- Application: ANDA204572
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 22 January 2025
- Application: ANDA207308
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Exelon for labeling indication on January 22, 2025. This approval was granted to AMNEAL PHARMS under standard expedited pathway. The application number for this approval is ANDA207308.
Exelon 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 Exelon approved in United States?
Yes. FDA authorised it on 17 November 2015; FDA authorised it on 2 November 2016; FDA authorised it on 13 February 2017.
Who is the marketing authorisation holder for Exelon in United States?
ALEMBIC PHARMS LTD holds the US marketing authorisation.