← FDA DRUG APPROVALS

FDA NDA · NDA022563

CALCIPOTRIENE

Sponsor: MAYNE PHARMA

APPLICATION
NDA022563
TYPE
NDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2019-11-05
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Prescription

Products

SORILUX · ReferencePrescription
CALCIPOTRIENE 0.005% · AEROSOL, FOAM · TOPICAL

Approval history

2019-11-05Efficacy · Supplement 7 · standard — Letter ↗AP
2019-11-05Labeling · Supplement 8 · standard — Letter ↗AP
2019-05-06Efficacy · Supplement 6 · standard — Label ↗AP
2015-07-10Manufacturing (CMC) · Supplement 4 · standardAP
2012-09-27Efficacy · Supplement 2 · standard — Label ↗AP
2011-04-21Labeling · Supplement 1 · unknown — Letter ↗AP
2010-10-06Type 5 - New Formulation or New Manufacturer · 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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