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Last Updated: July 27, 2021

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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 four 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. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202236
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 0037-0245 0037-0245-06 1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY
DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals 0037-0245 0037-0245-23 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Paragraph IV (Patent) Challenges for 202236
Tradename Dosage Ingredient NDA Submissiondate
DYMISTA SPRAY, METERED;NASAL azelastine hydrochloride; fluticasone propionate 202236 2014-06-13

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
Patent:⤷  Try it FreePatent Expiration:Feb 29, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Dec 13, 2023Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.