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Generated: October 18, 2018

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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 two suppliers. 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. Sixteen 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
Pharmacology for NDA: 022203
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 Meda Pharmaceuticals 0037-0242 0037-0242-30 1 BOTTLE, SPRAY in 1 BOX (0037-0242-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203 NDA Meda Pharmaceuticals 0037-0243 0037-0243-04 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Oct 15, 2008TE:RLD:No
Regulatory Exclusivity Expiration:Feb 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 22, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

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