CIPLA FDA Approval ANDA 210435

ANDA 210435

CIPLA

FDA Drug Application

Application #210435

Application Sponsors

ANDA 210435CIPLA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL5MG0LENALIDOMIDELENALIDOMIDE
002CAPSULE;ORAL10MG0LENALIDOMIDELENALIDOMIDE
003CAPSULE;ORAL15MG0LENALIDOMIDELENALIDOMIDE
004CAPSULE;ORAL25MG0LENALIDOMIDELENALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-06STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210435
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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