DR REDDYS LABS LTD FDA Approval ANDA 205926

ANDA 205926

DR REDDYS LABS LTD

FDA Drug Application

Application #205926

Application Sponsors

ANDA 205926DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 5MG BASE0PRASUGRELPRASUGREL HYDROCHLORIDE
002TABLET;ORALEQ 10MG BASE0PRASUGRELPRASUGREL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-07STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205926
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRASUGREL","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRASUGREL","activeIngredients":"PRASUGREL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-07
        )

)

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