Orange Book product · Generic (ANDA)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE
At a glance
May 20, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2011
15 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CETIRIZINE HYDROCHLORIDE
Strength
5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 201546
Product number
001
Marketing status
OTC
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
- 2026CETIRIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220335 · RUBICON RESEARCH
- 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
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.
