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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

CSV Excel Print

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

Showing 1 to 1 of 1 entries

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

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
12/24/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
11/01/2021	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)
11/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)
11/27/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)
08/05/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)
12/28/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
04/03/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (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)
10/25/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)
05/05/2005	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)

Showing 1 to 11 of 11 entries

Labels for NDA 021470

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
11/01/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)
11/01/2021	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)
11/27/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)
11/27/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)
08/05/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)
12/28/2015	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)
04/03/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)
12/18/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)
10/25/2010	SUPPL-5	Labeling	Label (PDF)
05/05/2005	SUPPL-3	Efficacy-New Indication	Label (PDF)
12/24/2002	ORIG-1	Approval	Label (PDF)

Showing 1 to 11 of 11 entries

Therapeutic Equivalents for NDA 021470

FINACEA

GEL;TOPICAL; 15%
TE Code = AB

CSV Excel Print

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 SPECLT
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

Showing 1 to 5 of 5 entries

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