APPLICATION
ANDA087792
TYPE
ANDA
ORIGINAL APPROVAL
1982-10-13
LATEST ACTION
2016-12-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUOROURACILDiscontinued
FLUOROURACIL 50MG/ML · INJECTABLE · INJECTION
Approval history
2016-12-06Labeling · Supplement 6 · standardAP
1989-08-29Manufacturing (CMC) · Supplement 5AP
1986-05-28Manufacturing (CMC) · Supplement 2AP
1982-10-13OriginalAP
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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