APPCO FDA Approval ANDA 211061

ANDA 211061

APPCO

FDA Drug Application

Application #211061

Application Sponsors

ANDA 211061APPCO

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL0.5MG0HALOPERIDOLHALOPERIDOL
002TABLET;ORAL1MG0HALOPERIDOLHALOPERIDOL
003TABLET;ORAL2MG0HALOPERIDOLHALOPERIDOL
004TABLET;ORAL5MG0HALOPERIDOLHALOPERIDOL
005TABLET;ORAL10MG0HALOPERIDOLHALOPERIDOL
006TABLET;ORAL20MG0HALOPERIDOLHALOPERIDOL

FDA Submissions

UNKNOWN; ORIG1AP2020-01-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

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

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211061
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-08
        )

)

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