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FDA NDA · NDA020273

CALCIPOTRIENE

Sponsor: LEO PHARMA AS

APPLICATION
NDA020273
TYPE
NDA
ORIGINAL APPROVAL
1993-12-29
LATEST ACTION
2025-10-03
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

DOVONEX · ReferencePrescription
CALCIPOTRIENE 0.005% · OINTMENT · TOPICAL

Approval history

2025-10-03Labeling · Supplement 15 · standard — Label ↗AP
2015-03-11Labeling · Supplement 13 · standard — Label ↗AP
2014-07-03Manufacturing (CMC) · Supplement 12 · standardAP
2007-09-26Labeling · Supplement 9 · standard — Label ↗AP
2005-04-28Labeling · Supplement 8 · standard — Review ↗AP
2001-03-23Manufacturing (CMC) · Supplement 7 · standardAP
2000-01-11Labeling · Supplement 6 · standardAP
1999-07-07Efficacy · Supplement 4 · standard — Letter ↗AP
1999-03-11Manufacturing (CMC) · Supplement 5 · standardAP
1997-03-20Efficacy · Supplement 3 · standardAP
1996-08-15Efficacy · Supplement 1 · standardAP
1995-07-13Manufacturing (CMC) · Supplement 2 · standardAP
1993-12-29Type 1 - New Molecular Entity · Original · standardAP
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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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