BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Novartis
Dow
Boehringer Ingelheim
Federal Trade Commission
Accenture
Queensland Health
Baxter
Julphar
QuintilesIMS

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202039

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NDA 202039 describes FEXOFENADINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Teva, and Wockhardt Ltd, and is included in eight NDAs. It is available from ninety-two suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and two suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 202039
Tradename:FEXOFENADINE HYDROCHLORIDE ALLERGY
Applicant:Aurolife Pharma Llc
Ingredient:fexofenadine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202039
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 202039 ANDA Aurolife Pharma, LLC 13107-066 13107-066-05 1 BOTTLE in 1 CARTON (13107-066-05) > 500 TABLET, FILM COATED in 1 BOTTLE
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 202039 ANDA Aurolife Pharma, LLC 13107-067 13107-067-05 1 BOTTLE in 1 CARTON (13107-067-05) > 500 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Nov 19, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Nov 19, 2014TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength180MG
Approval Date:Nov 19, 2014TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Dow
Argus Health
Cerilliant
Harvard Business School
Queensland Health
Federal Trade Commission
Julphar
US Army
Colorcon

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