Details for New Drug Application (NDA): 077991
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NDA 077991 describes CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Pld Acquisitions, Ppi-dac, Sun Pharm Inds Ltd, and Unichem, and is included in six NDAs. It is available from twenty-five suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
The generic ingredient in CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 077991
| Tradename: | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
| Applicant: | Pld Acquisitions |
| Ingredient: | cetirizine hydrochloride; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;120MG | ||||
| Approval Date: | Mar 5, 2008 | TE: | RLD: | No | |||||
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