Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207589
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENSTILAR BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% AEROSOL, FOAM;TOPICAL Prescription None 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
10/16/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2019 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
07/30/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
07/30/2019 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
06/20/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/08/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207589Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2019 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
07/30/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
07/30/2019 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
03/08/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf
10/16/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf

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