DR REDDYS LABS LTD FDA Approval ANDA 205374

ANDA 205374

DR REDDYS LABS LTD

FDA Drug Application

Application #205374

Application Sponsors

ANDA 205374DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL40MG0FEBUXOSTATFEBUXOSTAT
002TABLET;ORAL80MG0FEBUXOSTATFEBUXOSTAT

FDA Submissions

UNKNOWN; ORIG1AP2020-10-22STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205374
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)

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