Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022185
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% SUSPENSION;TOPICAL Prescription None Yes Yes
TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE 0.064%;0.005% SUSPENSION;TOPICAL Prescription 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
05/09/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022185s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022185_taclonex_scalp_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022185s000_SUMR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2019 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022185s027lbl.pdf
06/19/2017 SUPPL-25 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022185s025lbl.pdf
06/21/2016 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf
03/18/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/05/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/28/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf
10/29/2015 SUPPL-19 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf
08/29/2014 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf
02/26/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf
11/07/2013 SUPPL-15 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf
06/28/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/30/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s012ltr.pdf
10/17/2012 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf
03/20/2009 SUPPL-3 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2019 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022185s027lbl.pdf
06/19/2017 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022185s025lbl.pdf
06/21/2016 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf
10/29/2015 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf
08/29/2014 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf
07/28/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf
11/07/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf
11/07/2013 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf
11/30/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf
10/17/2012 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English