← FDA DRUG APPROVALS

FDA NDA · NDA022185

TACLONEX

calcipotriene and betamethasone dipropionate

Sponsor: LEO PHARMA AS

APPLICATION
NDA022185
TYPE
NDA
ORIGINAL APPROVAL
2008-05-09
LATEST ACTION
2019-07-25
ROUTE
TOPICAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

TACLONEX · ReferencePrescription
BETAMETHASONE DIPROPIONATE 0.064%, CALCIPOTRIENE 0.005% · SUSPENSION · TOPICAL
TACLONEX · ReferencePrescription
BETAMETHASONE DIPROPIONATE 0.064%, CALCIPOTRIENE HYDRATE 0.005% · SUSPENSION · TOPICAL

Approval history

2019-07-25Efficacy · Supplement 27 · standard — Label ↗AP
2017-06-19Manufacturing (CMC) · Supplement 25 — Label ↗AP
2016-06-21Manufacturing (CMC) · Supplement 24 — Label ↗AP
2016-03-18Manufacturing (CMC) · Supplement 23 · standardAP
2016-02-05Manufacturing (CMC) · Supplement 22 · standardAP
2015-10-29Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2014-08-29Efficacy · Supplement 18 · standard — Pediatric Medical Review ↗AP
2014-07-28Labeling · Supplement 20 · standard — Label ↗AP
2014-02-26Manufacturing (CMC) · Supplement 17 · standardAP
2013-11-07Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2013-11-07Labeling · Supplement 16 · standard — Label ↗AP
2013-06-28Manufacturing (CMC) · Supplement 14 · standardAP
2012-11-30Labeling · Supplement 12 · unknown — Letter ↗AP
2012-10-17Efficacy · Supplement 10 · standard — Label ↗AP
2009-03-20Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2008-05-09Type 3 - New Dosage Form · Original · standard — Summary Review ↗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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