HETERO LABS LTD III FDA Approval ANDA 079234

ANDA 079234

HETERO LABS LTD III

FDA Drug Application

Application #079234

Application Sponsors

ANDA 079234HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL5MG0TORSEMIDETORSEMIDE
002TABLET;ORAL10MG0TORSEMIDETORSEMIDE
003TABLET;ORAL20MG0TORSEMIDETORSEMIDE
004TABLET;ORAL100MG0TORSEMIDETORSEMIDE

FDA Submissions

ORIG1AP2009-01-27
LABELING; LabelingSUPPL3AP2013-01-07STANDARD

Submissions Property Types

SUPPL1Null15
SUPPL3Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79234
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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