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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020273
Company: LEO PHARMA AS

Products on NDA 020273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOVONEX	CALCIPOTRIENE	0.005%	OINTMENT;TOPICAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020273

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.

Labels for NDA 020273

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

Therapeutic Equivalents for NDA 020273

DOVONEX

OINTMENT;TOPICAL; 0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	OINTMENT;TOPICAL	Prescription	No	AB	090633	GLENMARK PHARMS INC
DOVONEX	CALCIPOTRIENE	0.005%	OINTMENT;TOPICAL	Prescription	Yes	AB	020273	LEO PHARMA AS

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