FDA — authorised 28 February 2001
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
🇺🇸 Razadyne in United States
FDA authorised Razadyne on 28 February 2001
Marketing authorisations
FDA — authorised 30 January 2009
- Application: ANDA078185
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 29 March 2011
- Application: ANDA090957
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 31 August 2015
- Application: ANDA090178
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA077604
- Marketing authorisation holder: YABAO PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 24 October 2019
- Application: ANDA204895
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
Razadyne 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 Razadyne approved in United States?
Yes. FDA authorised it on 28 February 2001; FDA authorised it on 30 January 2009; FDA authorised it on 29 March 2011.
Who is the marketing authorisation holder for Razadyne in United States?
JANSSEN PHARMS holds the US marketing authorisation.