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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 204507


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NDA 204507 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Rising, Sciegen Pharms, Sun Pharm Inds, Teva, and Wockhardt, and is included in six NDAs. It is available from forty-three 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 six suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 204507
Tradename:FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:Sciegen Pharms
Ingredient:fexofenadine hydrochloride
Patents:0
Pharmacology for NDA: 204507
Mechanism of ActionHistamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 204507
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204507 ANDA Major Pharmaceuticals 0904-7050 0904-7050-40 500 TABLET in 1 BOTTLE, PLASTIC (0904-7050-40)
FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204507 ANDA Major Pharmaceuticals 0904-7050 0904-7050-60 100 TABLET in 1 BOTTLE, PLASTIC (0904-7050-60)

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Sep 16, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength180MG
Approval Date:Sep 16, 2015TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Sep 16, 2015TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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