APPLICATION
ANDA090368
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-05
LATEST ACTION
2024-01-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
FLUOROURACILPrescription
FLUOROURACIL 5% · CREAM · TOPICAL
Approval history
2024-01-30Labeling · Supplement 12 · standardAP
2022-11-07Labeling · Supplement 11 · standardAP
2010-03-05OriginalAP
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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