DR REDDYS FDA Approval ANDA 209348

ANDA 209348

DR REDDYS

FDA Drug Application

Application #209348

Documents

Letter2021-11-02
Letter2021-11-02

Application Sponsors

ANDA 209348DR REDDYS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE;ORAL2.5MG0LENALIDOMIDELENALIDOMIDE
002CAPSULE;ORAL20MG0LENALIDOMIDELENALIDOMIDE
003CAPSULE; ORAL5MG0LENALIDOMIDELENALIDOMIDE
004CAPSULE; ORAL10MG0LENALIDOMIDELENALIDOMIDE
005CAPSULE; ORAL15MG0LENALIDOMIDELENALIDOMIDE
006CAPSULE; ORAL25MG0LENALIDOMIDELENALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-14STANDARD
UNKNOWN; ORIG2TA2021-10-14STANDARD

Submissions Property Types

ORIG1Null15
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

DR REDDYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209348
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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