Orange Book product · Generic (ANDA)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Mar 08, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 08, 2023
3 yr 4 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
ANDA 212409
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- 2007ZYRTEC-D 12 HOURBrand (NDA)
NDA 021150 · KENVUE BRANDS
- 2024CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210507 · UNICHEM
- 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.
