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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Johnson and Johnson
Deloitte
Fuji
Queensland Health
UBS
Argus Health
Cerilliant
Harvard Business School

Generated: October 18, 2017

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 Dr Reddys Labs Ltd, Wockhardt Ltd, Actavis Mid Atlantic, Teva, Sun Pharm Inds, and Mylan, and is included in seven NDAs. It is available from eighty-six 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 three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for NDA: 203330

Tradename:
2
Applicant:
1
Ingredient:
1
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 0363-0052-94 1 BOTTLE in 1 CARTON (0363-0052-94) > 118 mL in 1 BOTTLE
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride
SUSPENSION;ORAL 203330 ANDA Actavis Pharma, Inc. 0472-0527 0472-0527-94 1 BOTTLE in 1 CARTON (0472-0527-94) > 118 mL in 1 BOTTLE

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Healthtrust
Cerilliant
Julphar
Mallinckrodt
Teva
Cantor Fitzgerald
QuintilesIMS
Medtronic

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