Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020611
Company: LEO PHARM
Company: LEO PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOVONEX | CALCIPOTRIENE | 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/03/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020611ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/26/2007 | SUPPL-7 | 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-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020611s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020611s006ltr.pdf | |
01/11/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/11/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/31/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/26/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf | |
04/28/2005 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020611s006lbl.pdf |