FDA — authorised 3 March 2005
- Application: NDA021605
- Marketing authorisation holder: ORGANON
- Local brand name: CLARINEX D 24 HOUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Clarinex in United States
FDA authorised Clarinex on 3 March 2005
Marketing authorisations
FDA — authorised 14 December 2006
- Application: NDA021165
- Marketing authorisation holder: ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 19 February 2010
- Application: ANDA078357
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2010
- Application: ANDA078367
- Marketing authorisation holder: REDDYS
- Local brand name: DESLORATADINE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 25 October 2010
- Application: ANDA078352
- Marketing authorisation holder: LUPIN PHARMS
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2010
- Application: ANDA078359
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 2010
- Application: ANDA078364
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2011
- Application: ANDA078365
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2011
- Application: ANDA078366
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2011
- Application: ANDA078361
- Marketing authorisation holder: PERRIGO
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2012
- Application: ANDA078351
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2012
- Application: ANDA078355
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2015
- Application: ANDA202592
- Marketing authorisation holder: TARO
- Local brand name: DESLORATADINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 October 2015
- Application: NDA021313
- Marketing authorisation holder: ORGANON LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 26 May 2016
- Application: ANDA202936
- Marketing authorisation holder: TARO
- Local brand name: DESLORATADINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA078362
- Marketing authorisation holder: GLENMARK GENERICS
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078353
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: DESLORATADINE
- Indication: TABLET — ORAL
- Status: approved
Clarinex 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 Clarinex approved in United States?
Yes. FDA authorised it on 3 March 2005; FDA authorised it on 14 December 2006; FDA authorised it on 19 February 2010.
Who is the marketing authorisation holder for Clarinex in United States?
ORGANON holds the US marketing authorisation.