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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 Meda Pharms and is included in one NDA. There are two 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. Twelve suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for NDA: 022203

Meda Pharms
azelastine hydrochloride
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Oct 15, 2008TE:RLD:No
Patent:8,071,073Patent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Aug 30, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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