GLENMARK PHARMS LTD FDA Approval ANDA 216357

ANDA 216357

GLENMARK PHARMS LTD

FDA Drug Application

Application #216357

Application Sponsors

ANDA 216357GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL20MG0NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE
002CAPSULE;ORAL30MG0NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216357
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-16
        )

)

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