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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
McKinsey
Fish and Richardson
Julphar
US Army
Healthtrust
Merck
Fuji
Mallinckrodt

Generated: June 18, 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 thirteen 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. Nineteen 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 55111-557-07

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:

Merck
Julphar
US Department of Justice
Harvard Business School
Cerilliant
Medtronic
AstraZeneca
Cantor Fitzgerald
Covington

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