Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207071
Company: LEO PHARMA AS
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 |