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FDA NDA · NDA020554

CALCIPOTRIENE

Sponsor: LEO PHARMA AS

APPLICATION
NDA020554
TYPE
NDA
ORIGINAL APPROVAL
1996-07-22
LATEST ACTION
2025-10-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

DOVONEX · ReferencePrescription
CALCIPOTRIENE 0.005% · CREAM · TOPICAL

Approval history

2025-10-03Labeling · Supplement 13 · standard — Label ↗AP
2015-03-11Labeling · Supplement 12 · standard — Letter ↗AP
2014-06-12Manufacturing (CMC) · Supplement 9 · standardAP
2014-01-14Manufacturing (CMC) · Supplement 10 · standardAP
2013-11-21Manufacturing (CMC) · Supplement 11 · standardAP
2007-09-26Labeling · Supplement 7 · standard — Letter ↗AP
2005-04-28Labeling · Supplement 6 · standard — Letter ↗AP
2001-03-23Manufacturing (CMC) · Supplement 5 · standardAP
2000-01-11Labeling · Supplement 4 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 3 · standardAP
1998-12-18Manufacturing (CMC) · Supplement 1 · standardAP
1996-07-22Type 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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