FDA NDA · NDA020985

FLUOROURACIL

fluorouracil cream, 0.5%

Sponsor: EXTROVIS

APPLICATION

NDA020985

TYPE

NDA

ORIGINAL APPROVAL

2000-10-27

LATEST ACTION

2025-07-01

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Prescription

Products

CARAC · ReferencePrescription

FLUOROURACIL 0.5% · CREAM · TOPICAL

2025-07-01Manufacturing (CMC) · Supplement 21 — Label ↗AP

2022-05-26Labeling · Supplement 19 · standard — Label ↗AP

2015-04-29Manufacturing (CMC) · Supplement 17 · standardAP

2014-11-20Manufacturing (CMC) · Supplement 16 · standardAP

2003-12-16Labeling · Supplement 4 · standard — Label ↗AP

2002-11-15Manufacturing (CMC) · Supplement 3 · standardAP

2001-07-02Manufacturing (CMC) · Supplement 2 · standardAP

2001-01-29Labeling · Supplement 1 · standardAP

2000-10-27Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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