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Last Updated: February 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077170

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NDA 077170 describes CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Perrigo R And D, Pld Acquisitions, and Sun Pharm Inds Ltd, and is included in four 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.
Suppliers and Packaging for NDA: 077170
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077170 ANDA L. Perrigo Company 0113-0176 0113-0176-53 2 BLISTER PACK in 1 CARTON (0113-0176-53) > 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077170 ANDA L. Perrigo Company 0113-0176 0113-0176-62 4 BLISTER PACK in 1 CARTON (0113-0176-62) > 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Feb 25, 2008TE:RLD:No

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