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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 077081


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NDA 077081 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, and Wockhardt, and is included in six NDAs. It is available from fifty-five suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and one suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 077081
Tradename:FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:Rising
Ingredient:fexofenadine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:Apr 16, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Apr 11, 2008TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Apr 11, 2008TE:ABRLD:No

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