ANDA 216137

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #216137

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 216137

ZYDUS WORLDWIDE DMCC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	CAPSULE;ORAL	40MG	0	VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE
002	CAPSULE;ORAL	60MG	0	VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE
003	CAPSULE;ORAL	80MG	0	VALBENAZINE TOSYLATE	VALBENAZINE TOSYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS WORLDWIDE DMCC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216137
            [companyName] => ZYDUS WORLDWIDE DMCC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALBENAZINE TOSYLATE","activeIngredients":"VALBENAZINE TOSYLATE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALBENAZINE TOSYLATE","activeIngredients":"VALBENAZINE TOSYLATE","strength":"60MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VALBENAZINE TOSYLATE","activeIngredients":"VALBENAZINE TOSYLATE","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-13
        )

)