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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077954

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NDA 077954 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 077954
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: 077954
Suppliers and Packaging for NDA: 077954
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 077954 ANDA Physicians Total Care, Inc. 54868-6131 E 54868-6131-0
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 077954 ANDA Apotex Corp. 60505-0833 N 60505-0833-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Apr 30, 2009TE:ABRLD:No

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