Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021470
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FINACEA AZELAIC ACID 15% GEL;TOPICAL Prescription AB Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 204637 GLENMARK PHARMS
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 210549 TARO
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 208724 TOLMAR
FINACEA AZELAIC ACID 15% GEL;TOPICAL Prescription Yes AB 021470 LEO PHARMA AS

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