← FDA DRUG APPROVALS

FDA NDA · NDA021067

ASMANEX

mometasone furoate

Sponsor: ORGANON LLC

APPLICATION
NDA021067
TYPE
NDA
ORIGINAL APPROVAL
2005-03-30
LATEST ACTION
2021-02-16
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ASMANEX TWISTHALER · ReferencePrescription
MOMETASONE FUROATE 0.11MG/INH · POWDER · INHALATION
ASMANEX TWISTHALER · ReferencePrescription
MOMETASONE FUROATE 0.22MG/INH · POWDER · INHALATION

Approval history

2021-02-16Labeling · Supplement 32 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 29 · standard — Letter ↗AP
2018-03-26Labeling · Supplement 28 · standard — Label ↗AP
2018-03-26Labeling · Supplement 26 · standard — Label ↗AP
2016-12-15Manufacturing (CMC) · Supplement 25 · standardAP
2015-08-03Manufacturing (CMC) · Supplement 24 · standardAP
2010-09-17Labeling · Supplement 13 · standard — Label ↗AP
2008-02-26Labeling · Supplement 7 · standard — Letter ↗AP
2008-02-01Efficacy · Supplement 3 · standard — Label ↗AP
2005-03-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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