Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021852
Company: LEO PHARMA AS
Company: LEO PHARMA AS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TACLONEX | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
01/09/2006 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021852s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/21/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021852s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021852Orig1s020Ltr.pdf | |
07/28/2014 | SUPPL-16 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s016ltr.pdf | |
12/23/2014 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021852Orig1s015ltr.pdf | |
03/13/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/25/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/30/2012 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021852Orig1s012ltr.pdf | |
06/12/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/30/2010 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021852s006ltr.pdf | |
09/26/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021852s002ltr.pdf | |
09/15/2006 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/21/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021852s020lbl.pdf | |
12/23/2014 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s015lbl.pdf | |
07/28/2014 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021852s016lbl.pdf | |
11/30/2012 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021852s012lbl.pdf | |
03/30/2010 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021852s006lbl.pdf | |
09/26/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021852s002lbl.pdf | |
01/09/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021852lbl.pdf |
TACLONEX
OINTMENT;TOPICAL; 0.064%;0.005%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | OINTMENT;TOPICAL | Prescription | No | AB | 200174 | PADAGIS ISRAEL |
TACLONEX | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | OINTMENT;TOPICAL | Prescription | Yes | AB | 021852 | LEO PHARMA AS |