Application Sponsors
ANDA 214321 | HETERO LABS LTD III | |
Marketing Status
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | 100MG | 0 | POSACONAZOLE | POSACONAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-12-08 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 214321
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"100MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-12-08
)
)