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 |
| 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 |