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QuintilesIMS

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203330

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NDA 203330 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Actavis Mid Atlantic, Taro Pharm, Dr Reddys Labs Ltd, Mylan, Sun Pharm Inds, Teva, and Wockhardt Ltd, and is included in eight NDAs. It is available from eighty-five suppliers. Additional details are available on the CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in CHILDREN'S 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 203330
Tradename:CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
Applicant:Actavis Mid Atlantic
Ingredient:fexofenadine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203330
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 203330 ANDA Walgreen Company 0363-0052 N 0363-0052-94
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 203330 ANDA Actavis Pharma, Inc. 0472-0527 N 0472-0527-94

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Nov 18, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Nov 18, 2014TE:RLD:No

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