Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021852
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;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
01/09/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021852s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021852s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021852Orig1s020Ltr.pdf
07/28/2014 SUPPL-16 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s016ltr.pdf
12/23/2014 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s015ltr.pdf
03/13/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/25/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/30/2012 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021852Orig1s012ltr.pdf
06/12/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/30/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021852s006ltr.pdf
09/26/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021852s002ltr.pdf
09/15/2006 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021852s020lbl.pdf
12/23/2014 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf
07/28/2014 SUPPL-16 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf
11/30/2012 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf
03/30/2010 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf
09/26/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf
01/09/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf

TACLONEX

OINTMENT;TOPICAL; 0.064%;0.005%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;TOPICAL Prescription No AB 200174 PERRIGO UK FINCO
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;TOPICAL Prescription No AB 201615 TOLMAR
TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT;TOPICAL Prescription Yes AB 021852 LEO PHARMA AS

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