Dymista

Relieves symptoms of seasonal allergic rhinitis. NDA 202236, held by Mylan Speciality LP. Azelastine Hydrochloride; Fluticasone Propionate.

As of Nov 13, 2026, NDA 202236 (Dymista), held by Mylan Speciality LP, was first approved by FDA on May 1, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: May 1, 2012
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Feb 20, 2015	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Medical Review
May 1, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dymista0.137MG/SPRAY;0.05MG/SPRAY · spray, metered;nasal	Azelastine Hydrochloride; Fluticasone Propionate	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Dec 17, 2024	Supplement 21Labeling · Standard review	Approved	Label Letter
Apr 16, 2021	Supplement 13Labeling · Standard review	Approved	Label Letter
Sep 6, 2018	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 6, 2017	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 20, 2015	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Medical Review
Oct 29, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 2, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 21, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 26, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 19, 2012	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 10, 2012	Supplement 1Labeling · Standard review	Approved	Label Letter
May 1, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202236
Drugs@FDA: Overview at FDA
Company: Mylan Specialty

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters