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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021852
Company: LEO PHARMA AS

Products on NDA 021852

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021852

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-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021852

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

Therapeutic Equivalents for NDA 021852

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	PADAGIS ISRAEL
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	OINTMENT;TOPICAL	Prescription	Yes	AB	021852	LEO PHARMA AS

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