Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022563
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORILUX CALCIPOTRIENE 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
10/06/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563_sorilux_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/27/2012 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf
04/21/2011 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/27/2012 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf
04/21/2011 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf
10/06/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf

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