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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Johnson and Johnson
Harvard Business School
Federal Trade Commission

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020114

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NDA 020114 describes ASTELIN, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the ASTELIN profile page.

The generic ingredient in ASTELIN is azelastine hydrochloride. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 020114
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020114
Suppliers and Packaging for NDA: 020114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA AUTHORIZED GENERIC Wallace Pharmaceuticals Inc. 51525-0294 N 51525-0294-3
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA Physicians Total Care, Inc. 54868-5072 E 54868-5072-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Nov 1, 1996TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Daiichi Sankyo
US Department of Justice
US Army
Farmers Insurance

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