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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 076502


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NDA 076502 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-four 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 four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 076502
Pharmacology for NDA: 076502
Suppliers and Packaging for NDA: 076502
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076502 ANDA Walgreens Company 0363-0783 0363-0783-24 4 BLISTER PACK in 1 CARTON (0363-0783-24) / 6 TABLET in 1 BLISTER PACK
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076502 ANDA Walgreens Company 0363-0784 0363-0784-07 1 BLISTER PACK in 1 CARTON (0363-0784-07) / 5 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 11, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Apr 11, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength180MG
Approval Date:Apr 11, 2006TE:ABRLD:No

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