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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Boehringer Ingelheim
Julphar
Daiichi Sankyo
Federal Trade Commission
US Army
Medtronic
Johnson and Johnson

Generated: April 19, 2018

DrugPatentWatch Database Preview

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 Ivax Sub Teva Pharms, Pld Acquisitions, and Sun Pharm Inds Ltd, and is included in three NDAs. It is available from thirty-three 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. Thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Pharmacology for NDA: 077991
Suppliers and Packaging for NDA: 077991
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 077991 ANDA Physicians Total Care, Inc. 54868-5884 E 54868-5884-0
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077991 ANDA Physicians Total Care, Inc. 54868-5884 E 54868-5884-2

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Mar 5, 2008TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fuji
US Department of Justice
Farmers Insurance
Teva
Argus Health
Citi
Cerilliant
McKesson

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