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FDA NDA · NDA017010

TRIDESILON CREAM

desonide 0.05%

Sponsor: PADAGIS US

APPLICATION
NDA017010
TYPE
NDA
ORIGINAL APPROVAL
1972-01-04
LATEST ACTION
2016-11-02
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

DESONIDE · ReferenceDiscontinued
DESONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2016-11-02Manufacturing (CMC) · Supplement 23 · standardAP
2014-05-15Manufacturing (CMC) · Supplement 22 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 17 · standardAP
2000-03-17Manufacturing (CMC) · Supplement 16 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 15 · standardAP
1995-06-12Labeling · Supplement 14 · standardAP
1991-03-08Labeling · Supplement 13AP
1983-01-05Manufacturing (CMC) · Supplement 12 · standardAP
1982-12-06Labeling · Supplement 9AP
1982-09-16Manufacturing (CMC) · Supplement 11 · standardAP
1980-12-16Manufacturing (CMC) · Supplement 8 · standardAP
1980-05-01Manufacturing (CMC) · Supplement 7 · standardAP
1979-04-19Labeling · Supplement 6AP
1979-04-17Manufacturing (CMC) · Supplement 5 · standardAP
1976-02-12Manufacturing (CMC) · Supplement 4 · standardAP
1974-04-10Supplement · Supplement 2 · standardAP
1972-01-04Type 1 - New Molecular Entity · Original · standardReviewAP
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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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