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FDA NDA · NDA020279

DERMATOP E EMOLLIENT

Sponsor: VALEANT BERMUDA

APPLICATION
NDA020279
TYPE
NDA
ORIGINAL APPROVAL
1993-10-29
LATEST ACTION
2010-12-06
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

DERMATOP E EMOLLIENT · ReferenceDiscontinued
PREDNICARBATE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2010-12-06Labeling · Supplement 9 · standard — Label ↗AP
1998-09-15Manufacturing (CMC) · Supplement 4 · standardAP
1996-05-03Efficacy · Supplement 1 · standardAP
1995-02-24Manufacturing (CMC) · Supplement 2 · standardAP
1993-10-29Type 3 - New Dosage Form · Original · 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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