Application Sponsors
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS, SUBCUTANEOUS | 100MG/VIAL | 0 | AZACITIDINE | AZACITIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-27 | STANDARD |
Submissions Property Types
CDER Filings
LUPIN LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210748
[companyName] => LUPIN LTD
[docInserts] => ["",""]
[products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-27
)
)