Application Sponsors
Marketing Status
Application Products
001 | CREAM;TOPICAL | 10% | 0 | DOCOSANOL | DOCOSANOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-10-07 | STANDARD |
Submissions Property Types
CDER Filings
ENCUBE
cder:Array
(
[0] => Array
(
[ApplNo] => 212385
[companyName] => ENCUBE
[docInserts] => ["",""]
[products] => [{"drugName":"DOCOSANOL","activeIngredients":"DOCOSANOL","strength":"10%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-10-07
)
)