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Last Updated: May 27, 2022

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 Bayer Hlthcare and is included in two NDAs. 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
Tradename:ASTEPRO
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Patents:3
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength0.137MG/SPRAY
Approval Date:Oct 15, 2008TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Nov 22, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength0.2055MG/SPRAY
Approval Date:Aug 31, 2009TE:RLD:No
Patent:See Plans and PricingPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?

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