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FDA NDA · NDA020611

DOVONEX

Sponsor: LEO PHARM

APPLICATION
NDA020611
TYPE
NDA
ORIGINAL APPROVAL
1997-03-03
LATEST ACTION
2007-09-26
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

DOVONEX · ReferenceDiscontinued
CALCIPOTRIENE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · TOPICAL

Approval history

2007-09-26Labeling · Supplement 7 · standard — Label ↗AP
2005-04-28Labeling · Supplement 6 · standard — Label ↗AP
2000-01-11Labeling · Supplement 5 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 4 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 2 · standardAP
1997-03-03Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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