BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Healthtrust
Mallinckrodt
Citi
Deloitte
Accenture
Harvard Business School
US Department of Justice
Express Scripts

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078738

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NDA 078738 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex Inc, Sandoz Inc, Sun Pharma Global, Alkem Labs Ltd, Amneal Pharms Llc, Breckenridge Pharm, Perrigo Israel, Upsher-smith Labs, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. It is available from twelve suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 078738
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Sun Pharma Global
Ingredient:azelastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078738
Suppliers and Packaging for NDA: 078738
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078738 ANDA Sun Pharma Global FZE 47335-938 47335-938-90 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) > 6 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Jun 21, 2010TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
US Army
Chubb
Chinese Patent Office
Teva
Johnson and Johnson
Mallinckrodt
UBS
Deloitte

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