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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Farmers Insurance
US Department of Justice

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090176

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NDA 090176 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 fourteen 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 090176
Applicant:Breckenridge Pharm
Ingredient:azelastine hydrochloride
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090176
Suppliers and Packaging for NDA: 090176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 090176 ANDA AvKARE, Inc. 42291-153 N 42291-153-30
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 090176 ANDA Breckenridge Pharmaceutical, Inc. 51991-814 N 51991-814-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Jul 28, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
Argus Health
Federal Trade Commission

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