Application Sponsors
ANDA 215688 | ASCENT PHARMS INC | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-12-01 | STANDARD |
Submissions Property Types
CDER Filings
ASCENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215688
[companyName] => ASCENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-12-01
)
)