Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020273
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOVONEX CALCIPOTRIENE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/11/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf
07/03/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/26/2007 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf
04/28/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020273s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020273_s008_DOVONEX.pdf
03/23/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/2000 SUPPL-6 Labeling

Label is not available on this site.

03/11/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1999 SUPPL-4 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20273s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20273S004_Dovonex.pdf
03/20/1997 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

07/13/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1996 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/11/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf
09/26/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf
04/28/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf

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