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FDA NDA · NDA019568

DERMATOP

Sponsor: VALEANT PHARMS NORTH

APPLICATION
NDA019568
TYPE
NDA
ORIGINAL APPROVAL
1991-09-23
LATEST ACTION
2010-12-06
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

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PREDNICARBATE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2010-12-06Labeling · Supplement 14 · standard — Label ↗AP
2004-07-02Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
1998-09-15Manufacturing (CMC) · Supplement 5 · standardAP
1995-06-15Manufacturing (CMC) · Supplement 3 · standardAP
1994-01-07Manufacturing (CMC) · Supplement 1 · standardAP
1991-09-23Type 2 - New Active Ingredient · 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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