Orange Book product · Brand (NDA)

DYMISTA

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Brand (NDA)NDA 202236TE ABRX MYLAN SPECIALITY LP

May 01, 2012

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 01, 2012
14 yr 4 mo ago
Patent 8168620 expires
Listed drug product patent expiration.
Feb 24, 2026
4 mo ago
Today
Patent 8168620*PED expires
Listed listed patent expiration.
Aug 24, 2026
in 2 mo

Active ingredient

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Strength

0.137MG/SPRAY;0.05MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Application

NDA 202236

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8168620	Feb 24, 2026	4 mo ago	Product
8168620*PED	Aug 24, 2026	in 2 mo