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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204097

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NDA 204097 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, Unique Pharm Labs, and Wockhardt Ltd, and is included in nine NDAs. It is available from one hundred and three 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 thirteen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 204097
Tradename:FEXOFENADINE HYDROCHLORIDE ALLERGY
Applicant:Hetero Labs Ltd V
Ingredient:fexofenadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204097 ANDA Hetero Labs Limited 68554-5061 68554-5061-0 1 BOTTLE in 1 CARTON (68554-5061-0) > 30 TABLET, FILM COATED in 1 BOTTLE
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204097 ANDA Hetero Labs Limited 68554-5061 68554-5061-1 1 BOTTLE in 1 CARTON (68554-5061-1) > 100 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Aug 19, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Aug 19, 2016TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength180MG
Approval Date:Aug 19, 2016TE:RLD:No

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