← FDA DRUG APPROVALS

FDA NDA · NDA021758

VANOS

fluocinonide

Sponsor: BAUSCH

APPLICATION
NDA021758
TYPE
NDA
ORIGINAL APPROVAL
2005-02-11
LATEST ACTION
2016-12-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

VANOS · ReferencePrescription
FLUOCINONIDE 0.1% · CREAM · TOPICAL

Approval history

2016-12-22Manufacturing (CMC) · Supplement 19 · standardAP
2016-03-18Manufacturing (CMC) · Supplement 18 · standardAP
2012-03-16Labeling · Supplement 17 · unknown — Letter ↗AP
2011-11-10Labeling · Supplement 16 · unknown — Letter ↗AP
2010-12-30Labeling · Supplement 14 · unknown — Label ↗AP
2010-03-08Labeling · Supplement 12 · standard — Letter ↗AP
2006-12-13Labeling · Supplement 7 · standard — Label ↗AP
2006-03-13Manufacturing (CMC) · Supplement 3AP
2006-03-02Efficacy · Supplement 1 · standard — Letter ↗AP
2005-11-23Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2005-02-11Type 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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