FDA — authorised 12 April 1993
- Application: NDA019658
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: CLARITIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Claritin® in United States
FDA authorised Claritin® on 12 April 1993
Marketing authorisations
FDA — authorised 23 August 2006
- Application: NDA021891
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: CLARITIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 16 June 2008
- Application: NDA021952
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: CLARITIN
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is Claritin® approved in United States?
Yes. FDA authorised it on 12 April 1993; FDA authorised it on 23 August 2006; FDA authorised it on 16 June 2008.
Who is the marketing authorisation holder for Claritin® in United States?
BAYER HEALTHCARE LLC holds the US marketing authorisation.