Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020554
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOVONEX CALCIPOTRIENE 0.005% CREAM;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
07/22/1996 ORIG-1 Approval Type 3 - New Dosage Form 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-12 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
11/21/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/14/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/26/2007 SUPPL-7 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-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020554s006ltr.pdf
03/23/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/2000 SUPPL-4 Labeling

Label is not available on this site.

03/11/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1998 SUPPL-1 Manufacturing (CMC)-Control

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-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf
09/26/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf
04/28/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020554s006lbl.pdf

DOVONEX

CREAM;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% CREAM;TOPICAL Prescription No AB 205772 GLENMARK PHARMS
CALCIPOTRIENE CALCIPOTRIENE 0.005% CREAM;TOPICAL Prescription No AB 200935 TOLMAR
DOVONEX CALCIPOTRIENE 0.005% CREAM;TOPICAL Prescription Yes AB 020554 LEO PHARMA AS

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