DR REDDYS FDA Approval ANDA 211539

ANDA 211539

DR REDDYS

FDA Drug Application

Application #211539

Documents

Letter2021-02-02

Application Sponsors

ANDA 211539DR REDDYS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL500MG0VIGABATRINVIGABATRIN

FDA Submissions

UNKNOWN; ORIG1AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

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