GLENMARK PHARMS LTD FDA Approval ANDA 077662

ANDA 077662

GLENMARK PHARMS LTD

FDA Drug Application

Application #077662

Application Sponsors

ANDA 077662GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL600MG0GABAPENTINGABAPENTIN
002TABLET;ORAL800MG0GABAPENTINGABAPENTIN

FDA Submissions

ORIG1AP2006-08-18
LABELING; LabelingSUPPL6AP2009-11-20
LABELING; LabelingSUPPL8AP2011-08-29
LABELING; LabelingSUPPL9AP2011-09-29
LABELING; LabelingSUPPL10AP2011-11-25
LABELING; LabelingSUPPL13AP2014-03-25STANDARD
LABELING; LabelingSUPPL15AP2016-11-08STANDARD
LABELING; LabelingSUPPL17AP2016-11-08STANDARD
LABELING; LabelingSUPPL19AP2016-11-08STANDARD
LABELING; LabelingSUPPL21AP2017-10-05STANDARD
LABELING; LabelingSUPPL23AP2020-10-27STANDARD
LABELING; LabelingSUPPL26AP2020-10-27STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL8Null15
SUPPL9Null15
SUPPL10Null7
SUPPL13Null15
SUPPL15Null15
SUPPL17Null15
SUPPL19Null15
SUPPL21Null15
SUPPL23Null15
SUPPL26Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77662
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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