APPLICATION
ANDA040023
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-18
LATEST ACTION
1999-09-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ADRUCILDiscontinued
FLUOROURACIL 50MG/ML · INJECTABLE · INJECTION
Approval history
1999-09-13Labeling · Supplement 6AP
1997-09-12Labeling · Supplement 4AP
1992-11-04Manufacturing (CMC) · Supplement 3AP
1992-07-10Manufacturing (CMC) · Supplement 1AP
1991-10-18OriginalAP
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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