FDA — authorised 27 September 1996
- Application: NDA020346
- Marketing authorisation holder: J AND J CONSUMER INC
- Local brand name: ZYRTEC
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Zyrtec in United States
FDA authorised Zyrtec on 27 September 1996
Marketing authorisations
FDA — authorised 12 August 2016
- Application: ANDA207235
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA205291
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA209107
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 3 March 2020
- Application: ANDA076601
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA090922
- Marketing authorisation holder: SUN PHARM INDS LTD
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to SUN PHARM INDS LTD for Zyrtec on 20 May 2025. The approval was issued under the standard expedited pathway. The approved indication for Zyrtec is listed in the labelling.
Zyrtec 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 Zyrtec approved in United States?
Yes. FDA authorised it on 27 September 1996; FDA authorised it on 12 August 2016; FDA authorised it on 21 July 2017.
Who is the marketing authorisation holder for Zyrtec in United States?
J AND J CONSUMER INC holds the US marketing authorisation.