APPLICATION
ANDA076942
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-11
LATEST ACTION
2020-02-18
ROUTE
TOPICAL
DOSAGE FORM
SHAMPOO
MARKETING STATUS
Prescription
Products
KETOCONAZOLEPrescription
KETOCONAZOLE 2% · SHAMPOO · TOPICAL
Approval history
2020-02-18Labeling · Supplement 24 · standardAP
2015-08-31Labeling · Supplement 20 · standardAP
2013-01-03Labeling · Supplement 19 · standardAP
2007-10-17Manufacturing (CMC) · 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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