Documents
Application Sponsors
Marketing Status
Application Products
001 | CREAM;TOPICAL | 0.005% | 1 | DOVONEX | CALCIPOTRIENE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-07-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-03-11 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2000-01-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-03-23 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2005-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2007-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2014-06-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2014-01-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2013-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2015-03-11 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 6 |
TE Codes
CDER Filings
LEO PHARMA AS
cder:Array
(
[0] => Array
(
[ApplNo] => 20554
[companyName] => LEO PHARMA AS
[docInserts] => ["",""]
[products] => [{"drugName":"DOVONEX","activeIngredients":"CALCIPOTRIENE","strength":"0.005%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/11\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020273s013,020554s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020611s007,020554s007,020273s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020554s006lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DOVONEX","submission":"CALCIPOTRIENE","actionType":"0.005%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-03-11
)
)