APPLICATION
ANDA078837
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-07
LATEST ACTION
2025-04-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
IMIQUIMODPrescription
IMIQUIMOD 5% · CREAM · TOPICAL
Approval history
2025-04-25Labeling · Supplement 14 · standardAP
2013-07-31Labeling · Supplement 2AP
2010-09-07OriginalAP
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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