FDA — authorised 20 August 2014
- Application: ANDA202217
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Not Applicable
- Status: approved
🇺🇸 Halflytely in United States
FDA authorised Halflytely on 20 August 2014
Marketing authorisation
Halflytely 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 Halflytely approved in United States?
Yes. FDA authorised it on 20 August 2014.
Who is the marketing authorisation holder for Halflytely in United States?
NOVEL LABS INC holds the US marketing authorisation.