MARKSANS PHARMA FDA Approval ANDA 090007

ANDA 090007

MARKSANS PHARMA

FDA Drug Application

Application #090007

Application Sponsors

ANDA 090007MARKSANS PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL100MG0GABAPENTINGABAPENTIN
002CAPSULE;ORAL300MG0GABAPENTINGABAPENTIN
003CAPSULE;ORAL400MG0GABAPENTINGABAPENTIN

FDA Submissions

ORIG1AP2011-07-21
LABELING; LabelingSUPPL2AP2014-11-08STANDARD
LABELING; LabelingSUPPL3AP2020-08-20STANDARD
LABELING; LabelingSUPPL4AP2020-08-20STANDARD
LABELING; LabelingSUPPL5AP2020-08-20STANDARD
LABELING; LabelingSUPPL6AP2020-08-20STANDARD
LABELING; LabelingSUPPL8AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null7
SUPPL4Null7
SUPPL5Null15
SUPPL6Null15
SUPPL8Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90007
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"400MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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