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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021470
Company: LEO PHARMA AS

Products on NDA 021470

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021470

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021470lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2021	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021470s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021470Orig1s017ltr.pdf
11/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021470s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021470Orig1s015, 021470Orig1s016ltr.pdf
11/27/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021470s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021470Orig1s015, 021470Orig1s016ltr.pdf
08/05/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021470s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021470Orig1s013ltr.pdf
12/28/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470s012ltr.pdf
04/03/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021470Orig1s010ltr.pdf
02/03/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/23/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/18/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021470s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021470Orig1s007ltr.pdf
10/25/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021470s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021470s005ltr.pdf
05/05/2005	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021470s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021470s003ltr.pdf

Labels for NDA 021470

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021470s017lbl.pdf
11/01/2021	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021470s017lbl.pdf
11/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021470s015s016lbl.pdf
11/27/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021470s015s016lbl.pdf
08/05/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021470s013lbl.pdf
12/28/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s012lbl.pdf
04/03/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021470s010lbl.pdf
12/18/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021470s007lbl.pdf
10/25/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021470s005lbl.pdf
05/05/2005	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021470s003lbl.pdf
12/24/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021470lbl.pdf

Therapeutic Equivalents for NDA 021470

FINACEA

GEL;TOPICAL; 15%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZELAIC ACID	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	No	AB	208011	ACTAVIS LABS UT INC
AZELAIC ACID	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	No	AB	208724	ENCUBE
AZELAIC ACID	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	No	AB	204637	GLENMARK PHARMS
AZELAIC ACID	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	No	AB	210549	TARO
FINACEA	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	Yes	AB	021470	LEO PHARMA AS

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