GLENMARK PHARMS LTD FDA Approval ANDA 090032

ANDA 090032

GLENMARK PHARMS LTD

FDA Drug Application

Application #090032

Application Sponsors

ANDA 090032GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL20MG0TELMISARTANTELMISARTAN
002TABLET;ORAL40MG0TELMISARTANTELMISARTAN
003TABLET;ORAL80MG0TELMISARTANTELMISARTAN

FDA Submissions

ORIG1AP2014-07-07
LABELING; LabelingSUPPL2AP2015-11-17STANDARD
LABELING; LabelingSUPPL5AP2021-03-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2021-10-15

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL5Null7
SUPPL6Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90032
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TELMISARTAN","submission":"TELMISARTAN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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