SANDOZ INC FDA Approval ANDA 216068

ANDA 216068

SANDOZ INC

FDA Drug Application

Application #216068

Documents

Letter2022-09-07

Application Sponsors

ANDA 216068SANDOZ INC

Marketing Status

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

Application Products

001TABLET;ORAL40MG0ENZALUTAMIDEENZALUTAMIDE
002TABLET;ORAL80MG0ENZALUTAMIDEENZALUTAMIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-08-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216068
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENZALUTAMIDE","activeIngredients":"ENZALUTAMIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ENZALUTAMIDE","activeIngredients":"ENZALUTAMIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-02
        )

)

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