PAR PHARM INC FDA Approval ANDA 211290

ANDA 211290

PAR PHARM INC

FDA Drug Application

Application #211290

Documents

Letter2021-12-20

Application Sponsors

ANDA 211290PAR PHARM INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL40MG0ISOSORBIDE DINITRATEISOSORBIDE DINITRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.