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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald

Generated: December 15, 2017

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. Fourteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 020114

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 51525-0294-3 1 BOTTLE, SPRAY in 1 BOX (51525-0294-3) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA Physicians Total Care, Inc. 54868-5072 54868-5072-0 1 BOTTLE, SPRAY in 1 BOX (54868-5072-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020114

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality LpASTELINazelastine hydrochlorideSPRAY, METERED;NASAL020114-001Nov 1, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Harvard Business School

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