FDA — authorised 30 March 2009
- Application: ANDA090474
- Marketing authorisation holder: APOZEAL PHARMS
- Status: approved
🇺🇸 cetrizine in United States
FDA authorised cetrizine on 30 March 2009
Marketing authorisations
FDA
- Status: approved
cetrizine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is cetrizine approved in United States?
Yes. FDA authorised it on 30 March 2009; FDA has authorised it.
Who is the marketing authorisation holder for cetrizine in United States?
APOZEAL PHARMS holds the US marketing authorisation.