ANDA 215962

SANDOZ INC

FDA Drug Application

Application #215962

Documents

• Letter: 2023-01-10

Application Sponsors

ANDA 215962

SANDOZ INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	40MG	0	VALBENAZINE	VALBENAZINE
002	CAPSULE;ORAL	80MG	0	VALBENAZINE	VALBENAZINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)