Drugs@FDA: FDA-Approved Drugs

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

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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