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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207071
Company: LEO PHARMA AS

Summary Review

Products on NDA 207071

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FINACEA	AZELAIC ACID	15%	AEROSOL, FOAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2015	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/2015/207071s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207071Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207071Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207071Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207071s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207071Orig1s002,s004ltr.pdf
12/01/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207071s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207071Orig1s002,s004ltr.pdf

Labels for NDA 207071

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207071s002s004lbl.pdf
12/01/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207071s002s004lbl.pdf
07/29/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207071s000lbl.pdf

Therapeutic Equivalents for NDA 207071

FINACEA

AEROSOL, FOAM;TOPICAL; 15%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FINACEA	AZELAIC ACID	15%	AEROSOL, FOAM;TOPICAL	Prescription	Yes	AB	207071	LEO PHARMA AS

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