Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021470
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% | 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 |
---|---|---|---|---|---|
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 |
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 |
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 |