Picato

NDA 202833, held by Leo Labs. Ingenol Mebutate.

As of Nov 14, 2026, NDA 202833 (Picato), held by Leo Labs, was first approved by FDA on Jan 23, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 23, 2012
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Nov 19, 2015	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 23, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Picato0.015% · gel;topical	Ingenol Mebutate	DiscontinuedReference drug
Picato0.05% · gel;topical	Ingenol Mebutate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Mar 19, 2021	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 17, 2020	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 13, 2020	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 26, 2017	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 13, 2016	Supplement 7Labeling · Standard review	Approved	Letter Label
Apr 15, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 19, 2015	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 6, 2015	Supplement 5Labeling · Standard review	Approved	Review Label Letter
Feb 3, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 12, 2014	Supplement 2Labeling · Standard review	Approved	Label Letter
Jan 23, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 202833
Drugs@FDA: Overview at FDA
Company: LEO Labs

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters