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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Army
Mallinckrodt
Julphar
Colorcon
Merck
Cantor Fitzgerald
Harvard Business School
Moodys
Novartis
UBS

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202743

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NDA 202743 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 202743

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202743

Suppliers and Packaging for NDA: 202743

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 202743 ANDA Perrigo New York Inc 45802-026 45802-026-83 1 BOTTLE in 1 CARTON (45802-026-83) > 200 SPRAY in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.1876MG BASE/SPRAY
Approval Date:May 8, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Dow
QuintilesIMS
Moodys
Fuji
Merck
McKinsey
Johnson and Johnson
Federal Trade Commission
UBS
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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