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Last Updated: March 8, 2021

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Details for New Drug Application (NDA): 022203

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NDA 022203 describes ASTEPRO, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASTEPRO profile page.

The generic ingredient in ASTEPRO 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 022203
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203 NDA AUTHORIZED GENERIC Wallace Pharmaceuticals Inc. 51525-0234 51525-0234-3 1 BOTTLE in 1 CARTON (51525-0234-3) > 200 SPRAY, METERED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022203
Tradename Dosage Ingredient NDA Submissiondate
ASTEPRO SPRAY, METERED;NASAL azelastine hydrochloride 022203 2011-12-15

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Oct 15, 2008TE:RLD:No
Patent:  Start TrialPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 22, 2025Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.1876MG BASE/SPRAY
Approval Date:Aug 31, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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