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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Dow
Healthtrust
Citi
Julphar
Queensland Health
Fish and Richardson
Medtronic
Farmers Insurance

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078621

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NDA 078621 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 seventeen NDAs. It is available from fifteen 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 078621
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Apotex Inc
Ingredient:azelastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078621
Suppliers and Packaging for NDA: 078621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078621 ANDA Apotex Corp. 60505-0578 N 60505-0578-4

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Aug 3, 2009TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Cantor Fitzgerald
Cerilliant
Baxter
Cipla
UBS
QuintilesIMS
Deloitte

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