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Last Updated: January 16, 2021

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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, Granules, Hetero Labs Ltd V, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique Pharm Labs, and Wockhardt Ltd, and is included in ten NDAs. 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. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 202039
Applicant:Aurolife Pharma Llc
Ingredient:fexofenadine hydrochloride
Formulation / Manufacturing:see details

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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