INDOCO REMEDIES FDA Approval ANDA 206155

ANDA 206155

INDOCO REMEDIES

FDA Drug Application

Application #206155

Application Sponsors

ANDA 206155INDOCO REMEDIES

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL2.5MG0OLANZAPINEOLANZAPINE
002TABLET;ORAL5MG0OLANZAPINEOLANZAPINE
003TABLET;ORAL7.5MG0OLANZAPINEOLANZAPINE
004TABLET;ORAL10MG0OLANZAPINEOLANZAPINE
005TABLET;ORAL15MG0OLANZAPINEOLANZAPINE
006TABLET;ORAL20MG0OLANZAPINEOLANZAPINE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-31STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

INDOCO REMEDIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206155
            [companyName] => INDOCO REMEDIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-31
        )

)

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