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Serving leading biopharmaceutical companies globally:

Queensland Health
Julphar
QuintilesIMS
Argus Health
Healthtrust
Mallinckrodt
US Army
Fish and Richardson
McKinsey
Citi

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079043

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NDA 079043 describes FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharma Global, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
Pharmacology for NDA: 079043
Suppliers and Packaging for NDA: 079043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 079043 ANDA Safeway Inc 21130-557 N 21130-557-35
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 079043 ANDA Dr.Reddy's Laboratories Limited 55111-557 N 55111-557-35

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG;240MG
Approval Date:Jun 22, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Chubb
Johnson and Johnson
Fuji
Julphar
Daiichi Sankyo
Moodys
UBS
Cipla

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