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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202039


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NDA 202039 describes FEXOFENADINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique, and Wockhardt, and is included in ten NDAs. It is available from eighty-nine 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 four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 202039
Pharmacology for NDA: 202039
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 7-eleven 10202-229 10202-229-66 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK
FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 202039 ANDA 7-eleven 10202-229 10202-229-66 1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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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