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Generated: November 18, 2018

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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, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Teva, and Wockhardt Ltd, and is included in six NDAs. It is available from ninety-two 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 nine suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 077081
Tradename:FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:Mylan
Ingredient:fexofenadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 077081 ANDA Mylan Pharmaceuticals Inc. 0378-0781 0378-0781-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-05)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 077081 ANDA Mylan Pharmaceuticals Inc. 0378-0781 0378-0781-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-91)

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:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 11, 2008TE:ABRLD:No

Profile for product number 003

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

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