ANDA 215707

ZYDUS

FDA Drug Application

Application #215707

Application Sponsors

ANDA 215707

ZYDUS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215707
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-19
        )

)