APPLICATION
NDA016765
TYPE
NDA
ORIGINAL APPROVAL
1970-07-31
LATEST ACTION
1998-11-30
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
FLUOROPLEXDiscontinued
FLUOROURACIL 1% · SOLUTION · TOPICAL
Approval history
1998-11-30Manufacturing (CMC) · Supplement 28 · standardAP
1997-06-30Manufacturing (CMC) · Supplement 27 · standardAP
1992-12-08Manufacturing (CMC) · Supplement 26 · standardAP
1987-01-28Labeling · Supplement 21AP
1986-11-12Manufacturing (CMC) · Supplement 25 · standardAP
1982-08-16Manufacturing (CMC) · Supplement 22 · standardAP
1982-08-13Manufacturing (CMC) · Supplement 23 · standardAP
1982-05-13Manufacturing (CMC) · Supplement 19 · standardAP
1981-05-15Manufacturing (CMC) · Supplement 20 · standardAP
1981-01-12Manufacturing (CMC) · Supplement 18 · standardAP
1980-09-18Manufacturing (CMC) · Supplement 17 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 16 · standardAP
1979-03-16Manufacturing (CMC) · Supplement 15 · standardAP
1978-04-17Manufacturing (CMC) · Supplement 14 · standardAP
1977-02-15Manufacturing (CMC) · Supplement 12 · standardAP
1976-09-03Labeling · Supplement 11AP
1976-07-01Manufacturing (CMC) · Supplement 10 · standardAP
1970-07-31Type 3 - New Dosage Form · 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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