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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Chubb
Daiichi Sankyo
Fuji
Teva
Medtronic
McKesson
Mallinckrodt

Generated: April 20, 2018

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 eleven 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.
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 walgreens 0363-2110 N 0363-2110-20
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818 ANDA walgreens 0363-2110 N 0363-2110-30

Profile 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 hundreds of leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Johnson and Johnson
Merck
Express Scripts
Moodys
Mallinckrodt
Chubb
US Army

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