FDA — authorised 25 July 1996
- Application: NDA020625
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: ALLEGRA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Allegra in United States
FDA authorised Allegra on 25 July 1996
Marketing authorisations
FDA — authorised 16 September 2015
- Application: ANDA204507
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 19 August 2016
- Application: ANDA204097
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 30 October 2017
- Application: ANDA209116
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 13 August 2018
- Application: ANDA210137
- Marketing authorisation holder: UNIQUE
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA215434
- Marketing authorisation holder: DR REDDYS
- Status: approved
Allegra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Allegra approved in United States?
Yes. FDA authorised it on 25 July 1996; FDA authorised it on 16 September 2015; FDA authorised it on 19 August 2016.
Who is the marketing authorisation holder for Allegra in United States?
CHATTEM SANOFI holds the US marketing authorisation.