APPLICATION
ANDA076419
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-07
LATEST ACTION
2015-08-31
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Prescription
Products
KETOCONAZOLEPrescription
KETOCONAZOLE 2% · SHAMPOO · TOPICAL
Approval history
2015-08-31Labeling · Supplement 15 · standardAP
2013-03-18Labeling · Supplement 12 · standardAP
2011-02-04Labeling · Supplement 10AP
2008-02-01Labeling · Supplement 4AP
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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