FDA — authorised 24 December 1997
- Application: NDA020786
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 FEXOFENADINE HYDROCHLORIDE in United States
FDA authorised FEXOFENADINE HYDROCHLORIDE on 24 December 1997
Marketing authorisations
FDA — authorised 19 October 2004
- Application: NDA021704
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2005
- Application: ANDA076236
- Marketing authorisation holder: BARR
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 July 2005
- Application: ANDA076169
- Marketing authorisation holder: BARR
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 2005
- Application: ANDA076191
- Marketing authorisation holder: BARR
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2006
- Application: ANDA076502
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2007
- Application: ANDA077081
- Marketing authorisation holder: RISING
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2007
- Application: NDA021909
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: CHILDREN'S ALLEGRA ALLERGY
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 17 March 2010
- Application: ANDA079043
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 November 2010
- Application: ANDA076298
- Marketing authorisation holder: IMPAX PHARMS
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 February 2012
- Application: ANDA091567
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2012
- Application: ANDA201311
- Marketing authorisation holder: P AND L
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 January 2013
- Application: ANDA202978
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 November 2014
- Application: ANDA076667
- Marketing authorisation holder: DR REDDYS
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 November 2014
- Application: ANDA203330
- Marketing authorisation holder: P AND L
- Local brand name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 November 2014
- Application: ANDA202039
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 2015
- Application: ANDA090818
- Marketing authorisation holder: SUN PHARM
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 September 2015
- Application: ANDA204507
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: FEXOFENADINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 2016
- Application: ANDA204097
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: FEXOFENADINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2017
- Application: ANDA209116
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 November 2017
- Application: ANDA208123
- Marketing authorisation holder: TARO
- Status: approved
FDA — authorised 13 August 2018
- Application: ANDA210137
- Marketing authorisation holder: UNIQUE
- Local brand name: FEXOFENADINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2019
- Application: ANDA211075
- Marketing authorisation holder: GRANULES
- Local brand name: FEXOFENADINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2020
- Application: ANDA212971
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA215434
- Marketing authorisation holder: DR REDDYS
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 May 2023
- Application: ANDA213466
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 February 2025
- Application: ANDA219032
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2025
- Application: ANDA215232
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA076970
- Marketing authorisation holder: RANBAXY
- Local brand name: FEXOFENADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA079115
- Marketing authorisation holder: WOCKHARDT
- Local brand name: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA077999
- Marketing authorisation holder: PLD ACQUISITIONS LLC
- Local brand name: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FEXOFENADINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FEXOFENADINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 24 December 1997; FDA authorised it on 19 October 2004; FDA authorised it on 14 April 2005.
Who is the marketing authorisation holder for FEXOFENADINE HYDROCHLORIDE in United States?
CHATTEM SANOFI holds the US marketing authorisation.