Orange Book product
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG
Orange Book ANDA 077170 · IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA · Over the counter
Key facts
| Proprietary name | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 5MG;120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA077170 |
| Applicant holder | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 25, 2008 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.