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FDA NDA · NDA021152

CUTIVATE

Sponsor: FOUGERA PHARMS

APPLICATION
NDA021152
TYPE
NDA
ORIGINAL APPROVAL
2005-03-31
LATEST ACTION
2015-01-16
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

CUTIVATE · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2015-01-16Efficacy · Supplement 4 · standard — Letter ↗AP
2014-12-19Manufacturing (CMC) · Supplement 3AP
2014-11-17Manufacturing (CMC) · Supplement 8 · standardAP
2013-04-24Manufacturing (CMC) · Supplement 6 · standardAP
2013-04-01Manufacturing (CMC) · Supplement 7 · standardAP
2011-05-12Labeling · Supplement 5 · unknown — Letter ↗AP
2010-09-03Labeling · Supplement 2 · standard — Letter ↗AP
2005-03-31Type 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.

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