FDA NDA · NDA202236

DYMISTA

azelastine hydrochloride and fluticasone propionate

Sponsor: MYLAN SPECIALITY LP

APPLICATION

NDA202236

TYPE

NDA

ORIGINAL APPROVAL

2012-05-01

LATEST ACTION

2024-12-17

ROUTE

NASAL

DOSAGE FORM

SPRAY, METERED

MARKETING STATUS

Prescription

Products

DYMISTA · ReferencePrescription

AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY, FLUTICASONE PROPIONATE 0.05MG/SPRAY · SPRAY, METERED · NASAL

2024-12-17Labeling · Supplement 21 · standard — Label ↗AP

2021-04-16Labeling · Supplement 13 · standard — Label ↗AP

2018-09-06Labeling · Supplement 10 · standard — Letter ↗AP

2017-01-06Manufacturing (CMC) · Supplement 9 · standardAP

2015-02-20Efficacy · Supplement 8 · priority — Label ↗AP

2014-10-29Manufacturing (CMC) · Supplement 7 · standardAP

2014-06-02Manufacturing (CMC) · Supplement 5 · standardAP

2014-01-21Manufacturing (CMC) · Supplement 4 · standardAP

2013-03-26Manufacturing (CMC) · Supplement 3 · standardAP

2012-11-19Manufacturing (CMC) · Supplement 2 · standardAP

2012-08-10Labeling · Supplement 1 · standard — Label ↗AP

2012-05-01Type 4 - New Combination · Original · standard — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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