Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020273
Company: LEO PHARMA AS
Company: LEO PHARMA AS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOVONEX | CALCIPOTRIENE | 0.005% | OINTMENT;TOPICAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/11/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020554Orig1s12,020273Orig1s13ltr.pdf | |
07/03/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2007 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf | |
04/28/2005 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020273s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020273_s008_DOVONEX.pdf | |
03/23/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/11/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/11/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/1999 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20273s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20273S004_Dovonex.pdf |
03/20/1997 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
07/13/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/15/1996 | SUPPL-1 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/11/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020273s013,020554s012lbl.pdf | |
09/26/2007 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf | |
04/28/2005 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020273s008lbl.pdf |
DOVONEX
OINTMENT;TOPICAL; 0.005%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | OINTMENT;TOPICAL | Prescription | No | AB | 090633 | GLENMARK PHARMS INC |
DOVONEX | CALCIPOTRIENE | 0.005% | OINTMENT;TOPICAL | Prescription | Yes | AB | 020273 | LEO PHARMA AS |