ANDA 216068

SANDOZ INC

FDA Drug Application

Application #216068

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 216068

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORAL	40MG	0	ENZALUTAMIDE	ENZALUTAMIDE
002	TABLET;ORAL	80MG	0	ENZALUTAMIDE	ENZALUTAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)