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FDA NDA · NDA021738

EXTINA

Sponsor: RISING

APPLICATION
NDA021738
TYPE
NDA
ORIGINAL APPROVAL
2007-06-12
LATEST ACTION
2018-06-20
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Discontinued

Products

EXTINA · ReferenceDiscontinued
KETOCONAZOLE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL, FOAM · TOPICAL

Approval history

2018-06-20Labeling · Supplement 7 · standardLabelAP
2007-06-12Type 3 - New Dosage Form · Original · standardLabelAP
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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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