Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202833
Company: LEO LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PICATO INGENOL MEBUTATE 0.015% GEL;TOPICAL Prescription AB Yes Yes
PICATO INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription AB Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

PICATO

GEL;TOPICAL; 0.015%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGENOL MEBUTATE INGENOL MEBUTATE 0.015% GEL;TOPICAL Prescription No AB 209018 PERRIGO UK FINCO
PICATO INGENOL MEBUTATE 0.015% GEL;TOPICAL Prescription Yes AB 202833 LEO LABS

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGENOL MEBUTATE INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription No AB 209019 PERRIGO UK FINCO
PICATO INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription Yes AB 202833 LEO LABS

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