ANDA 211539

DR REDDYS

FDA Drug Application

Application #211539

Documents

• Letter: 2021-02-02

Application Sponsors

ANDA 211539

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

VIGABATRIN

VIGABATRIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211539
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211539Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-29
        )

)