← FDA DRUG APPROVALS

FDA NDA · NDA202833

PICATO

Sponsor: LEO LABS

APPLICATION
NDA202833
TYPE
NDA
ORIGINAL APPROVAL
2012-01-23
LATEST ACTION
2021-03-19
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

PICATO · ReferenceDiscontinued
INGENOL MEBUTATE 0.015% · GEL · TOPICAL
PICATO · ReferenceDiscontinued
INGENOL MEBUTATE 0.05% · GEL · TOPICAL

Approval history

2021-03-19Labeling · Supplement 13 · standard — Letter ↗AP
2020-12-17Labeling · Supplement 12 · standard — Label ↗AP
2020-02-13Labeling · Supplement 11 · standard — Label ↗AP
2017-01-26Manufacturing (CMC) · Supplement 8 · standardAP
2016-09-13Labeling · Supplement 7 · standard — Letter ↗AP
2016-04-15Manufacturing (CMC) · Supplement 6 · standardAP
2015-11-19Efficacy · Supplement 4 · standard — Label ↗AP
2015-10-06Labeling · Supplement 5 · standard — Review ↗AP
2015-02-03Manufacturing (CMC) · Supplement 3 · standardAP
2014-03-12Labeling · Supplement 2 · standard — Letter ↗AP
2012-01-23Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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