Orange Book product · Brand (NDA)
ZYRTEC-D 12 HOUR
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Nov 09, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2007
18 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
5MG;120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021150
Product number
002
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210507 · UNICHEM
- 2023CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212409 · AUROBINDO PHARMA LTD
- 2018CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210719 · PPI-DAC
- 2012CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090922 · SUN PHARM INDS LTD
- 2008CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077991 · PLD ACQUISITIONS
- 2008CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077170 · IVAX SUB TEVA PHARMS
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.
