APPLICATION
NDA016988
TYPE
NDA
ORIGINAL APPROVAL
1971-08-06
LATEST ACTION
2022-02-28
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
FLUOROPLEX · ReferenceDiscontinued
FLUOROURACIL 1% · CREAM · TOPICAL
Approval history
2016-03-01Manufacturing (CMC) · Supplement 28 · standardAP
2016-01-29Manufacturing (CMC) · Supplement 29 · standardAP
2002-06-18Manufacturing (CMC) · Supplement 26 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 25 · standardAP
1998-11-30Manufacturing (CMC) · Supplement 24 · standardAP
1997-06-30Manufacturing (CMC) · Supplement 23 · standardAP
1992-12-08Manufacturing (CMC) · Supplement 22 · standardAP
1987-01-28Labeling · Supplement 20AP
1981-01-12Manufacturing (CMC) · Supplement 18 · standardAP
1980-09-18Manufacturing (CMC) · Supplement 16 · standardAP
1980-07-07Manufacturing (CMC) · Supplement 17 · standardAP
1978-04-17Manufacturing (CMC) · Supplement 15 · standardAP
1977-09-01Labeling · Supplement 14AP
1977-03-02Manufacturing (CMC) · Supplement 12 · standardAP
1976-08-06Manufacturing (CMC) · Supplement 11 · standardAP
1976-07-09Labeling · Supplement 10AP
1975-12-24Manufacturing (CMC) · Supplement 8 · standardAP
1974-12-17Manufacturing (CMC) · Supplement 7 · standardAP
1971-08-06Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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