➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Colorcon
Johnson and Johnson
Boehringer Ingelheim
McKinsey

Last Updated: August 2, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202743


Email this page to a colleague

« Back to Dashboard

NDA 202743 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, Apotex, and Perrigo Uk Finco, and is included in twenty-five NDAs. It is available from twenty 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. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202743
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Perrigo Israel
Ingredient:azelastine hydrochloride
Patents:0
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
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 202743 ANDA Bryant Ranch Prepack 63629-2519 63629-2519-1 1 BOTTLE in 1 CARTON (63629-2519-1) > 200 SPRAY in 1 BOTTLE

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Colorcon
Boehringer Ingelheim
Merck
AstraZeneca

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 verification 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.