FDA — authorised 23 August 1996
- Application: NDA020470
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: CLARITIN-D 24 HOUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Claritin in United States
FDA authorised Claritin on 23 August 1996
Marketing authorisations
FDA — authorised 19 December 2002
- Application: NDA021375
- Marketing authorisation holder: FDN CONSUMER
- Local brand name: ALAVERT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 21 January 2003
- Application: ANDA075209
- Marketing authorisation holder: PLD ACQUISITIONS LLC
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2003
- Application: ANDA076050
- Marketing authorisation holder: PERRIGO PHARMA INTL
- Local brand name: LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 February 2003
- Application: ANDA075822
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: LORATADINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 August 2003
- Application: ANDA076134
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2003
- Application: ANDA076154
- Marketing authorisation holder: MYLAN
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 2003
- Application: ANDA075505
- Marketing authorisation holder: TEVA
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 January 2004
- Application: ANDA076208
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 June 2004
- Application: NDA021512
- Marketing authorisation holder: PERRIGO
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 2004
- Application: ANDA076301
- Marketing authorisation holder: PERRIGO
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2004
- Application: ANDA076805
- Marketing authorisation holder: TARO
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 20 August 2004
- Application: ANDA076529
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 20 August 2004
- Application: ANDA075815
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 September 2004
- Application: ANDA076557
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 October 2004
- Application: ANDA075565
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 4 October 2005
- Application: NDA021734
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: LORATADINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 February 2006
- Application: ANDA076471
- Marketing authorisation holder: APOTEX
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2006
- Application: ANDA077421
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 August 2006
- Application: NDA021891
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: CHILDREN'S CLARITIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 11 April 2007
- Application: ANDA077153
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LORATADINE REDIDOSE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 31 July 2015
- Application: ANDA201865
- Marketing authorisation holder: TARO
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 16 April 2018
- Application: ANDA210088
- Marketing authorisation holder: SUN PHARM
- Local brand name: LORATADINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 16 April 2018
- Application: ANDA208314
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA208931
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA202538
- Marketing authorisation holder: BIONPHARMA
- Local brand name: LORATADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 March 2019
- Application: ANDA207569
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2019
- Application: ANDA210033
- Marketing authorisation holder: PERRIGO PHARMA INTL
- Local brand name: LORATADINE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA210722
- Marketing authorisation holder: GRANULES
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2020
- Application: ANDA212795
- Marketing authorisation holder: INSTAPILL
- Local brand name: LORATADINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 October 2020
- Application: ANDA213294
- Marketing authorisation holder: INSTAPILL
- Local brand name: LORATADINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 7 January 2021
- Application: ANDA214684
- Marketing authorisation holder: UNIQUE PHARM
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 May 2021
- Application: ANDA210409
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LORATADINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA211718
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2024
- Application: ANDA219223
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: LORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2025
- Application: ANDA215127
- Marketing authorisation holder: CATALENT PHARMA
- Local brand name: LORATADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Claritin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Claritin approved in United States?
Yes. FDA authorised it on 23 August 1996; FDA authorised it on 19 December 2002; FDA authorised it on 21 January 2003.
Who is the marketing authorisation holder for Claritin in United States?
BAYER HEALTHCARE LLC holds the US marketing authorisation.