SANDOZ INC FDA Approval ANDA 213570

ANDA 213570

SANDOZ INC

FDA Drug Application

Application #213570

Documents

Letter2022-09-27

Application Sponsors

ANDA 213570SANDOZ INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET; ORAL0.25MG0REXULTIBREXPIPRAZOLE
002TABLET; ORAL0.50MG0REXULTIBREXPIPRAZOLE
003TABLET; ORAL1MG0REXULTIBREXPIPRAZOLE
004TABLET; ORAL2MG0REXULTIBREXPIPRAZOLE
005TABLET; ORAL3MG0REXULTIBREXPIPRAZOLE
006TABLET; ORAL4MG0REXULTIBREXPIPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

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

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213570
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213570Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)

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