ANDA 215942

TEVA PHARMS INC

FDA Drug Application

Application #215942

Application Sponsors

ANDA 215942

TEVA PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	0	CABOZANTINIB	CABOZANTINIB
002	TABLET;ORAL	40MG	0	CABOZANTINIB	CABOZANTINIB
003	TABLET;ORAL	60MG	0	CABOZANTINIB	CABOZANTINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215942
            [companyName] => TEVA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABOZANTINIB","activeIngredients":"CABOZANTINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CABOZANTINIB","activeIngredients":"CABOZANTINIB","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CABOZANTINIB","activeIngredients":"CABOZANTINIB","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-27
        )

)