APPLICATION
ANDA078548
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-25
LATEST ACTION
2025-05-19
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
IMIQUIMODPrescription
IMIQUIMOD 5% · CREAM · TOPICAL
Approval history
2025-05-19Labeling · Supplement 13 · standardAP
2015-09-18Labeling · Supplement 2AP
2015-09-18Labeling · Supplement 7 · standardAP
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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