Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 40MG | 0 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-11-23 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211290
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-11-23
)
)