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Serving leading biopharmaceutical companies globally:

Covington
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091567

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NDA 091567 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 eighty-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 091567

Tradename:4
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 091567

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 091567 ANDA Sun Pharmaceutical Industries Limited 62756-542 62756-542-28 9 BLISTER PACK in 1 CARTON (62756-542-28) > 5 TABLET, FILM COATED in 1 BLISTER PACK
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 091567 ANDA Sun Pharmaceutical Industries Limited 62756-542 62756-542-30 15 BLISTER PACK in 1 CARTON (62756-542-30) > 6 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Feb 6, 2012TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength30MG
Approval Date:Feb 6, 2012TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength60MG
Approval Date:Feb 6, 2012TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
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Fish and Richardson
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Queensland Health
Mallinckrodt
Julphar

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