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Last Updated: July 5, 2020

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. Twenty 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
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 Meda Pharmaceuticals 0037-0241 0037-0241-30 1 BOTTLE, SPRAY in 1 BOX (0037-0241-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA Wallace Pharmaceuticals Inc. 51525-0294 51525-0294-3 1 BOTTLE, SPRAY in 1 BOX (51525-0294-3) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Paragraph IV (Patent) Challenges for 020114
Tradename Dosage Ingredient NDA Submissiondate
ASTELIN SPRAY, METERED;NASAL azelastine hydrochloride 020114 2005-11-14

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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