FDA — authorised 8 December 1995
- Application: NDA019835
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: ZYRTEC ALLERGY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CETIRIZINE HYDROCHLORIDE in United States
FDA authorised CETIRIZINE HYDROCHLORIDE on 8 December 1995 · 82,457 US adverse-event reports
Marketing authorisations
FDA — authorised 10 August 2001
- Application: NDA021150
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: ZYRTEC-D 12 HOUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 March 2004
- Application: NDA021621
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: CHILDREN'S ZYRTEC ALLERGY
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 16 November 2007
- Application: NDA022155
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: CHILDREN'S ZYRTEC ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA078336
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA077499
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA077946
- Marketing authorisation holder: PLD ACQUISITIONS
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA078317
- Marketing authorisation holder: APOTEX INC
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA077498
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA076677
- Marketing authorisation holder: MYLAN
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2007
- Application: ANDA076047
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2007
- Application: ANDA078615
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2007
- Application: ANDA078427
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2008
- Application: ANDA077631
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 15 January 2008
- Application: ANDA078343
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2008
- Application: ANDA078692
- Marketing authorisation holder: SANDOZ
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 25 February 2008
- Application: ANDA077170
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 March 2008
- Application: ANDA077991
- Marketing authorisation holder: PLD ACQUISITIONS
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 April 2008
- Application: ANDA090254
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 April 2008
- Application: ANDA090188
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 April 2008
- Application: ANDA090182
- Marketing authorisation holder: TARO
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 April 2008
- Application: ANDA090183
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 May 2008
- Application: ANDA090378
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 June 2008
- Application: ANDA078398
- Marketing authorisation holder: PADAGIS US
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 June 2008
- Application: ANDA078412
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 June 2008
- Application: ANDA076601
- Marketing authorisation holder: TARO
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 October 2008
- Application: ANDA090300
- Marketing authorisation holder: CYPRESS PHARM
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 February 2009
- Application: ANDA078862
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2009
- Application: ANDA090474
- Marketing authorisation holder: APOZEAL PHARMS
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 April 2009
- Application: ANDA078870
- Marketing authorisation holder: APOZEAL PHARMS
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 June 2009
- Application: ANDA078680
- Marketing authorisation holder: UNICHEM
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2009
- Application: ANDA078072
- Marketing authorisation holder: TARO
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2009
- Application: ANDA077829
- Marketing authorisation holder: UNIQUE
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 October 2009
- Application: ANDA090766
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 October 2009
- Application: ANDA090765
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 November 2009
- Application: ANDA090191
- Marketing authorisation holder: BAJAJ
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 2 February 2010
- Application: ANDA078617
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 April 2010
- Application: ANDA079191
- Marketing authorisation holder: TORRENT PHARMS LLC
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2010
- Application: ANDA078933
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 2010
- Application: NDA022578
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: ZYRTEC ALLERGY
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 22 April 2011
- Application: ANDA091130
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 May 2011
- Application: ANDA201546
- Marketing authorisation holder: TARO
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA090142
- Marketing authorisation holder: SUN PHARM
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 17 October 2011
- Application: ANDA091327
- Marketing authorisation holder: BAJAJ
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 May 2012
- Application: ANDA078876
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA090922
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 November 2012
- Application: ANDA090572
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 July 2013
- Application: ANDA077318
- Marketing authorisation holder: CIPLA LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 2013
- Application: ANDA204226
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 March 2014
- Application: ANDA202277
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 February 2015
- Application: ANDA091116
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 5 August 2015
- Application: ANDA090760
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 2015
- Application: ANDA205490
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 8 March 2016
- Application: ANDA206793
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 12 August 2016
- Application: ANDA207235
- Marketing authorisation holder: APOTEX
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 May 2017
- Application: NDA208694
- Marketing authorisation holder: HARROW EYE
- Local brand name: ZERVIATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA205291
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA209274
- Marketing authorisation holder: GRANULES
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA209107
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 November 2018
- Application: ANDA210719
- Marketing authorisation holder: PPI-DAC
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 May 2019
- Application: ANDA212266
- Marketing authorisation holder: QUAGEN
- Local brand name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 September 2020
- Application: ANDA213557
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA213105
- Marketing authorisation holder: CATALENT
- Local brand name: CETIRIZINE HYDROCHLORIDE ALLERGY
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 March 2023
- Application: ANDA212409
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 September 2024
- Application: ANDA210507
- Marketing authorisation holder: UNICHEM
- Local brand name: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 October 2024
- Application: ANDA218895
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2026
- Application: ANDA220335
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA077472
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: CETIRIZINE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 82,457
Most-reported reactions
- Drug Ineffective — 10,010 reports (12.14%)
- Pain — 9,719 reports (11.79%)
- Fatigue — 9,661 reports (11.72%)
- Alopecia — 8,032 reports (9.74%)
- Abdominal Discomfort — 7,866 reports (9.54%)
- Rheumatoid Arthritis — 7,834 reports (9.5%)
- Systemic Lupus Erythematosus — 7,676 reports (9.31%)
- Pemphigus — 7,511 reports (9.11%)
- Rash — 7,181 reports (8.71%)
- Glossodynia — 6,967 reports (8.45%)
CETIRIZINE 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 CETIRIZINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 8 December 1995; FDA authorised it on 10 August 2001; FDA authorised it on 16 March 2004.
Who is the marketing authorisation holder for CETIRIZINE HYDROCHLORIDE in United States?
KENVUE BRANDS holds the US marketing authorisation.