NATCO PHARMA LTD FDA Approval ANDA 207818

ANDA 207818

NATCO PHARMA LTD

FDA Drug Application

Application #207818

Application Sponsors

ANDA 207818NATCO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 100MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE
002TABLET;ORALEQ 400MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2019-03-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NATCO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207818
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-01
        )

)

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