Orange Book product · Brand (NDA)
ZYRTEC
CETIRIZINE HYDROCHLORIDE
At a glance
Sep 27, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CETIRIZINE HYDROCHLORIDE
Strength
5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 020346
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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
- 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.
