APPLICATION
ANDA077524
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-11
LATEST ACTION
2022-09-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
FLUOROURACILPrescription
FLUOROURACIL 5% · CREAM · TOPICAL
Approval history
2022-09-30Labeling · Supplement 12 · standardAP
2014-12-29Labeling · Supplement 2AP
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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