APPLICATION
NDA012209
TYPE
NDA
ORIGINAL APPROVAL
1962-04-25
LATEST ACTION
2016-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUOROURACIL · ReferenceDiscontinued
FLUOROURACIL 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
FLUOROURACIL · ReferenceDiscontinued
FLUOROURACIL 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-07-31Manufacturing (CMC) · Supplement 39 · priorityAP
1997-09-15Manufacturing (CMC) · Supplement 36 · priorityAP
1995-05-05Manufacturing (CMC) · Supplement 35 · priorityAP
1994-05-12Labeling · Supplement 33 · standardAP
1991-10-18Manufacturing (CMC) · Supplement 32 · priorityAP
1991-05-20Labeling · Supplement 31AP
1989-03-20Manufacturing (CMC) · Supplement 30 · priorityAP
1988-10-03Labeling · Supplement 29AP
1988-05-19Manufacturing (CMC) · Supplement 28 · priorityAP
1986-11-26Labeling · Supplement 26AP
1986-11-26Labeling · Supplement 20AP
1986-10-21Manufacturing (CMC) · Supplement 27 · priorityAP
1986-07-01Labeling · Supplement 23AP
1985-06-26Manufacturing (CMC) · Supplement 25 · priorityAP
1984-07-19Labeling · Supplement 21AP
1983-05-12Labeling · Supplement 19AP
1983-01-10Manufacturing (CMC) · Supplement 15 · priorityAP
1982-03-24Labeling · Supplement 18AP
1980-04-04Manufacturing (CMC) · Supplement 17 · priorityAP
1979-11-08Manufacturing (CMC) · Supplement 16 · priorityAP
1978-09-29Labeling · Supplement 14AP
1977-05-03Labeling · Supplement 13AP
1976-09-29Manufacturing (CMC) · Supplement 12 · priorityAP
1976-09-27Manufacturing (CMC) · Supplement 11 · priorityAP
1976-09-27Manufacturing (CMC) · Supplement 10 · priorityAP
1975-07-22Manufacturing (CMC) · Supplement 9 · priorityAP
1962-04-25Type 1 - New Molecular Entity · Original · priorityAP
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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