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Generated: May 20, 2019

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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 three 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. Eighteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 020114
Tradename:ASTELIN
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Patents:0
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 AUTHORIZED GENERIC A-S Medication Solutions 50090-2538 50090-2538-0 1 BOTTLE, SPRAY in 1 BOX (50090-2538-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

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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