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 is one patent 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. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

Summary for 202236

Tradename:	DYMISTA
Applicant:	Mylan Speciality Lp
Ingredient:	azelastine hydrochloride; fluticasone propionate
Patents:	1

Pharmacology for NDA: 202236

Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists

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	Viatris Specialty LLC	0037-0245	0037-0245-23	1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-3458	0378-3458-23	1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.137MG/SPRAY;0.05MG/SPRAY
Approval Date:	May 1, 2012	TE:	AB	RLD:	Yes
Patent:	8,168,620*PED	Patent Expiration:	Aug 24, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202236

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	8,163,723*PED	⤷ Get Started Free
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,901,585	⤷ Get Started Free
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,259,428*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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