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FDA NDA · NDA021852

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

Sponsor: LEO PHARMA AS

APPLICATION
NDA021852
TYPE
NDA
ORIGINAL APPROVAL
2006-01-09
LATEST ACTION
2018-12-21
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

TACLONEX · ReferencePrescription
BETAMETHASONE DIPROPIONATE 0.064%, CALCIPOTRIENE 0.005% · OINTMENT · TOPICAL

Approval history

2018-12-21Labeling · Supplement 20 · standard — Label ↗AP
2014-12-23Efficacy · Supplement 15 · standard — Pediatric Medical Review ↗AP
2014-07-28Labeling · Supplement 16 · standard — Letter ↗AP
2014-06-12Manufacturing (CMC) · Supplement 10 · standardAP
2014-03-13Manufacturing (CMC) · Supplement 14 · standardAP
2013-04-25Manufacturing (CMC) · Supplement 13 · standardAP
2012-11-30Labeling · Supplement 12 · unknown — Label ↗AP
2010-03-30Labeling · Supplement 6 · standard — Label ↗AP
2007-09-26Labeling · Supplement 2 · standard — Letter ↗AP
2006-09-15Manufacturing (CMC) · Supplement 1AP
2006-01-09Type 4 - New Combination · Original · standard — Label ↗AP
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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