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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022185
Company: LEO PHARMA AS

Summary Review

Products on NDA 022185

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	AB	Yes	Yes
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022185

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

Labels for NDA 022185

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

Therapeutic Equivalents for NDA 022185

TACLONEX

SUSPENSION;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%	SUSPENSION;TOPICAL	Prescription	No	AB	210765	COSETTE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	213269	TARO
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	212367	PADAGIS ISRAEL
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	Yes	AB	022185	LEO PHARMA AS

TACLONEX

SUSPENSION;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%	SUSPENSION;TOPICAL	Prescription	No	AB	210765	COSETTE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	213269	TARO
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	No	AB	212367	PADAGIS ISRAEL
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION;TOPICAL	Prescription	Yes	AB	022185	LEO PHARMA AS

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