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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Express Scripts

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202236

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NDA 202236 describes DYMISTA, 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 DYMISTA profile page.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202236
Applicant:Mylan Speciality Lp
Ingredient:azelastine hydrochloride; fluticasone propionate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals Inc. 0037-0245 N 0037-0245-06
DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals Inc. 0037-0245 N 0037-0245-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
Approval Date:May 1, 2012TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Aug 20, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:Feb 29, 2024Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Cantor Fitzgerald
Chinese Patent Office
Federal Trade Commission

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