ACTAVIS GROUP FDA Approval ANDA 200854

ANDA 200854

ACTAVIS GROUP

FDA Drug Application

Application #200854

Application Sponsors

ANDA 200854ACTAVIS GROUP

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

N/A; Not ApplicableORIG1AP2022-07-01

Submissions Property Types

ORIG1Null7

TE Codes

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

CDER Filings

ACTAVIS GROUP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200854
            [companyName] => ACTAVIS GROUP
            [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":"07\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-01
        )

)

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