DR REDDYS FDA Approval ANDA 212449

ANDA 212449

DR REDDYS

FDA Drug Application

Application #212449

Application Sponsors

ANDA 212449DR REDDYS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 84MG BASE0ELIGLUSTAT TARTRATEELIGLUSTAT TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212449
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELIGLUSTAT TARTRATE","activeIngredients":"ELIGLUSTAT TARTRATE","strength":"EQ 84MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)

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