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FDA NDA · NDA016831

FLUOROURACIL

Sponsor: EXTROVIS

APPLICATION
NDA016831
TYPE
NDA
ORIGINAL APPROVAL
1970-07-29
LATEST ACTION
2021-10-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM, SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

EFUDEX · ReferencePrescription
FLUOROURACIL 5% · CREAM · TOPICAL
EFUDEX · ReferencePrescription
FLUOROURACIL 2% · SOLUTION · TOPICAL
EFUDEX · ReferenceDiscontinued
FLUOROURACIL 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2021-10-14Labeling · Supplement 63 · standard — Label ↗AP
2015-11-04Manufacturing (CMC) · Supplement 59 · standardAP
2015-08-18Manufacturing (CMC) · Supplement 58 · standardAP
2015-05-06Manufacturing (CMC) · Supplement 57 · standardAP
2013-12-12Manufacturing (CMC) · Supplement 55 · standardAP
2013-07-02Manufacturing (CMC) · Supplement 56 · standardAP
2006-05-10Manufacturing (CMC) · Supplement 51 — Letter ↗AP
2005-10-13Labeling · Supplement 49 · standard — Letter ↗AP
2004-06-24Labeling · Supplement 47 · standard — Label ↗AP
2004-04-27Manufacturing (CMC) · Supplement 46 · standard — Letter ↗AP
2002-11-27Manufacturing (CMC) · Supplement 43 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 42 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 41 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 40 · standardAP
2001-02-12Manufacturing (CMC) · Supplement 39 · standardAP
2000-07-07Manufacturing (CMC) · Supplement 37 · standardAP
2000-07-07Manufacturing (CMC) · Supplement 36 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 38 · standardAP
2000-04-05Manufacturing (CMC) · Supplement 35 · standard — Review ↗AP
1998-11-02Manufacturing (CMC) · Supplement 33 · standardAP
1997-02-18Manufacturing (CMC) · Supplement 32 · standardAP
1995-03-21Labeling · Supplement 29AP
1993-08-05Manufacturing (CMC) · Supplement 31 · standard — Review ↗AP
1993-03-04Manufacturing (CMC) · Supplement 30 · standard — Review ↗AP
1988-11-30Manufacturing (CMC) · Supplement 28 · standard — Review ↗AP
1987-03-26Labeling · Supplement 17AP
1986-11-14Manufacturing (CMC) · Supplement 27 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 26 · standardAP
1985-03-14Manufacturing (CMC) · Supplement 25 · standardAP
1984-08-13Manufacturing (CMC) · Supplement 24 · standardAP
1984-05-04Manufacturing (CMC) · Supplement 23 · standardAP
1983-08-12Manufacturing (CMC) · Supplement 21 · standardAP
1983-08-12Manufacturing (CMC) · Supplement 22 · standardAP
1983-03-14Manufacturing (CMC) · Supplement 20 · standardAP
1982-05-14Manufacturing (CMC) · Supplement 19 · standardAP
1982-03-10Labeling · Supplement 18AP
1979-12-18Manufacturing (CMC) · Supplement 16 · standardAP
1979-10-23Manufacturing (CMC) · Supplement 15 · standardAP
1978-11-21Manufacturing (CMC) · Supplement 14 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 13 · standardAP
VIEW ON DRUGS@FDA ↗

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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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