Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Set up watchlists for daily email updates

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Johnson and Johnson
Argus Health
US Army
Harvard Business School

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090176

« Back to Dashboard
NDA 090176 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Sandoz Inc, Upsher-smith Labs, Apotex Inc, Sun Pharma Global, Perrigo Israel, West-ward Pharms Int, Akorn, and Breckenridge Pharm, and is included in twelve NDAs. It is available from ten 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 NDA: 090176

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
SPRAY, METERED;NASAL 090176 ANDA AvKARE, Inc. 42291-153 42291-153-30 1 BOTTLE, SPRAY in 1 CARTON (42291-153-30) > 30 mL in 1 BOTTLE, SPRAY
azelastine hydrochloride
SPRAY, METERED;NASAL 090176 ANDA Breckenridge Pharmaceutical, Inc. 51991-814 51991-814-03 1 BOTTLE, SPRAY in 1 CARTON (51991-814-03) > 30 mL in 1 BOTTLE, SPRAY

Summary for product number 001

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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
US Army
Farmers Insurance
Express Scripts

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:

Google Plus