← FDA DRUG APPROVALS

FDA NDA · NDA205641

ASMANEX HFA

mometasone furoate

Sponsor: ORGANON LLC

APPLICATION
NDA205641
TYPE
NDA
ORIGINAL APPROVAL
2014-04-25
LATEST ACTION
2019-08-12
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

ASMANEX HFA · ReferencePrescription
MOMETASONE FUROATE 0.20MG/INH · AEROSOL, METERED · INHALATION
ASMANEX HFA · ReferencePrescription
MOMETASONE FUROATE 0.05MG/INH · AEROSOL, METERED · INHALATION
ASMANEX HFA · ReferencePrescription
MOMETASONE FUROATE 0.10MG/INH · AEROSOL, METERED · INHALATION

Approval history

2019-08-12Efficacy · Supplement 10 · standard — Label ↗AP
2018-03-26Labeling · Supplement 8 · standard — Label ↗AP
2018-03-26Labeling · Supplement 7 · standard — Label ↗AP
2016-07-12Efficacy · Supplement 5 · standard — Label ↗AP
2015-08-06Manufacturing (CMC) · Supplement 1 · standardAP
2015-08-03Manufacturing (CMC) · Supplement 4 — Label ↗AP
2015-06-16Labeling · Supplement 2 · standard — Label ↗AP
2014-04-25Type 2 - New Active Ingredient and Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →