Application Sponsors
ANDA 205134 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
001 | CREAM;TOPICAL | 0.1% | 0 | HYDROCORTISONE BUTYRATE | HYDROCORTISONE BUTYRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-12-08 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 205134
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCORTISONE BUTYRATE","activeIngredients":"HYDROCORTISONE BUTYRATE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-12-08
)
)