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Last Updated: June 22, 2021

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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. 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
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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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