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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207589
Company: LEO PHARMA AS

Summary Review

Products on NDA 207589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENSTILAR	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	AEROSOL, FOAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207589Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207589s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207589Orig1s011ltr.pdf
10/16/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207589s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207589Orig1s010ltr.pdf
07/30/2019	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
07/30/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
07/30/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207589Orig1s005,s006,s007ltr.pdf
06/20/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/08/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207589Orig1s001ltr.pdf

Labels for NDA 207589

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207589s011lbl.pdf
10/16/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207589s010lbl.pdf
07/30/2019	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
07/30/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
07/30/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207589s005s006s007lbl.pdf
03/08/2016	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207589s001lbl.pdf
10/16/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207589s000lbl.pdf

Therapeutic Equivalents for NDA 207589

ENSTILAR

AEROSOL, FOAM;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%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	214688	GLENMARK PHARMS LTD
ENSTILAR	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	AEROSOL, FOAM;TOPICAL	Prescription	Yes	AB	207589	LEO PHARMA AS

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