Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022185
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% | SUSPENSION;TOPICAL | Prescription | AB | Yes | Yes |
| TACLONEX | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE | 0.064%;0.005% | SUSPENSION;TOPICAL | Prescription | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/25/2019 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022185s027lbl.pdf | |
| 06/19/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022185s025lbl.pdf | |
| 06/21/2016 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022185s024lbl.pdf | |
| 10/29/2015 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022185s019lbl.pdf |
| 08/29/2014 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s018lbl.pdf | |
| 07/28/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022185s020lbl.pdf | |
| 11/07/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf | |
| 11/07/2013 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022185Orig1s015, s016lbl.pdf |
| 11/30/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s012lbl.pdf | |
| 10/17/2012 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022185s010lbl.pdf |