Orange Book product · Generic (ANDA)
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE
At a glance
Feb 25, 2026
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 25, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
CETIRIZINE HYDROCHLORIDE
Strength
5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 220335
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CETIRIZINE HYDROCHLORIDE
- 2020CHILDREN'S ZYRTEC ALLERGYBrand (NDA)
NDA 021621 · KENVUE BRANDS
- 2019QUZYTTIRBrand (NDA)
NDA 211415 · ESTEVE
- 2017ZERVIATEBrand (NDA)
NDA 208694 · HARROW EYE
- 2010ZYRTEC ALLERGYBrand (NDA)
NDA 022578 · KENVUE BRANDS
- 2009CETIRIZINE HYDROCHLORIDE ALLERGYBrand (NDA)
NDA 022429 · BIONPHARMA
- 2007CHILDREN'S ZYRTEC ALLERGYBrand (NDA)
NDA 022155 · KENVUE BRANDS
- 1996ZYRTECBrand (NDA)
NDA 020346 · J AND J CONSUMER INC
- 2024CETIRIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218895 · REGCON HOLDINGS
- 2020CETIRIZINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 213105 · CATALENT
- 2020CETIRIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213557 · AUROBINDO PHARMA LTD
- 2019CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 212266 · QUAGEN
- 2019CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 210622 · HETERO LABS LTD III
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
