DR REDDYS LABS LTD FDA Approval ANDA 204345

ANDA 204345

DR REDDYS LABS LTD

FDA Drug Application

Application #204345

Application Sponsors

ANDA 204345DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL150MG0CAPECITABINECAPECITABINE
002TABLET;ORAL500MG0CAPECITABINECAPECITABINE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-04

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204345
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-04
        )

)

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