FDA Orange Book · active-ingredient family
Cetirizine hydrochloride; pseudoephedrine hydrochloride
Cetirizine hydrochloride; pseudoephedrine hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYRTEC-D 12 HOUR · NDA 021150
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYRTEC-D 12 HOURRLD | KENVUE BRANDS | NDA 021150 | — | Nov 09, 2007 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | UNICHEM | ANDA 210507 | — | Sep 10, 2024 | |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 212409 | — | Mar 08, 2023 | |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | PPI-DAC | ANDA 210719 | — | Nov 16, 2018 | |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | SUN PHARM INDS LTD | ANDA 090922 | — | Sep 28, 2012 | |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | PLD ACQUISITIONS | ANDA 077991 | — | Mar 05, 2008 | |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | IVAX SUB TEVA PHARMS | ANDA 077170 | — | Feb 25, 2008 |
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.
Cetirizine hydrochloride; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
