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FDA NDA · NDA019957

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Sponsor: FOUGERA

APPLICATION
NDA019957
TYPE
NDA
ORIGINAL APPROVAL
1990-12-14
LATEST ACTION
2021-03-19
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

CUTIVATE · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2021-03-19Labeling · Supplement 13 · standard — Letter ↗AP
2015-02-18Labeling · Supplement 12 · standard — Letter ↗AP
2002-01-18Efficacy · Supplement 11 · standard — Label ↗AP
2001-12-09Labeling · Supplement 7 · standard — Label ↗AP
2001-12-09Labeling · Supplement 9 · standard — Label ↗AP
2000-06-07Manufacturing (CMC) · Supplement 10 · standardAP
1999-06-30Manufacturing (CMC) · Supplement 8 · standardAP
1998-11-12Manufacturing (CMC) · Supplement 6 · standardAP
1995-08-17Labeling · Supplement 1AP
1995-06-07Manufacturing (CMC) · Supplement 5 · standardAP
1994-10-07Manufacturing (CMC) · Supplement 4 · standardAP
1994-10-07Manufacturing (CMC) · Supplement 2 · standardAP
1994-06-07Manufacturing (CMC) · Supplement 3 · standardAP
1990-12-14Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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