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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Fish and Richardson
Queensland Health

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090818

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NDA 090818 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 ten 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. Seventeen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 090818

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090818

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 090818 ANDA Sun Pharma Global FZE 47335-724 47335-724-83 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;120MG
Approval Date:Jan 29, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Farmers Insurance
Cantor Fitzgerald

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