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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202833
Company: LEO LABS

Products on NDA 202833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PICATO	INGENOL MEBUTATE	0.015%	GEL;TOPICAL	Discontinued	None	Yes	No
PICATO	INGENOL MEBUTATE	0.05%	GEL;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202833lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202833s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202833Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2021	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202833s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202833Orig1s013ltr.pdf
12/17/2020	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202833Orig1s012ltr.pdf
02/13/2020	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202833Orig1s011ltr.pdf
01/26/2017	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/13/2016	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202833s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202833Orig1s007ltr.pdf
04/15/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/06/2015	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/202833Orig1s005.pdf
11/19/2015	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202833Orig1s004ltr.pdf
02/03/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/12/2014	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202833Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202833Orig1s002ltr.pdf

Labels for NDA 202833

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202833s013lbl.pdf
03/19/2021	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202833s013lbl.pdf
12/17/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s012lbl.pdf
12/17/2020	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s012lbl.pdf
02/13/2020	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s011lbl.pdf
02/13/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202833s011lbl.pdf
09/13/2016	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202833s007lbl.pdf
11/19/2015	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s004lbl.pdf
10/06/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf
10/06/2015	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202833s005lbl.pdf
03/12/2014	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202833Orig1s002lbl.pdf
01/23/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202833lbl.pdf

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