SANDOZ INC FDA Approval ANDA 215962

ANDA 215962

SANDOZ INC

FDA Drug Application

Application #215962

Documents

Letter2023-01-10

Application Sponsors

ANDA 215962SANDOZ INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001CAPSULE;ORAL40MG0VALBENAZINEVALBENAZINE
002CAPSULE;ORAL80MG0VALBENAZINEVALBENAZINE

FDA Submissions

UNKNOWN; ORIG1TA2022-12-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215962
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALBENAZINE","activeIngredients":"VALBENAZINE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALBENAZINE","activeIngredients":"VALBENAZINE","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-12
        )

)

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