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FDA NDA · NDA020746

RHINOCORT ALLERGY

Sponsor: KENVUE BRANDS

APPLICATION
NDA020746
TYPE
NDA
ORIGINAL APPROVAL
1999-10-01
LATEST ACTION
2017-05-22
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter, Prescription, Discontinued

Products

RHINOCORT ALLERGY · ReferenceOver-the-counter
BUDESONIDE 0.032MG/SPRAY · SPRAY, METERED · NASAL
RHINOCORT · ReferencePrescription
BUDESONIDE 0.032MG/INH · SPRAY, METERED · NASAL
RHINOCORTDiscontinued
BUDESONIDE 0.064MG/INH · SPRAY, METERED · NASAL

Approval history

2017-05-22Labeling · Supplement 37 · standard — Letter ↗AP
2016-08-24Labeling · Supplement 36 · standard — Letter ↗AP
2016-04-22Labeling · Supplement 34 · standard — Label ↗AP
2016-03-10Labeling · Supplement 33 · standard — Letter ↗AP
2016-03-02Manufacturing (CMC) · Supplement 35 · standardAP
2015-03-23Efficacy · Supplement 32 · standard — Label ↗AP
2013-04-29Manufacturing (CMC) · Supplement 31 · standardAP
2010-12-28Labeling · Supplement 26 · unknown — Label ↗AP
2009-05-21Labeling · Supplement 24 · standard — Label ↗AP
2007-10-16Labeling · Supplement 21 · standard — Label ↗AP
2004-08-25Labeling · Supplement 15 · standard — Letter ↗AP
2004-07-30Efficacy · Supplement 16 · unknown — Letter ↗AP
2004-01-16Labeling · Supplement 13 · standard — Label ↗AP
2003-09-26Labeling · Supplement 11 · standard — Label ↗AP
2002-10-03Manufacturing (CMC) · Supplement 8 · standardAP
2002-05-31Manufacturing (CMC) · Supplement 7 · standardAP
2001-10-26Efficacy · Supplement 4 · standard — Letter ↗AP
2001-06-25Manufacturing (CMC) · Supplement 3 · standardAP
2001-06-18Manufacturing (CMC) · Supplement 5 · standardAP
2001-05-18Manufacturing (CMC) · Supplement 6 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 1 · standardAP
1999-10-01Type 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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