SUN PHARM FDA Approval ANDA 213914

ANDA 213914

SUN PHARM

FDA Drug Application

Application #213914

Documents

Letter2021-09-02

Application Sponsors

ANDA 213914SUN PHARM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORALEQ 12.5MG BASE0SUNITINIB MALATESUNITINIB MALATE
002CAPSULE;ORALEQ 25MG BASE0SUNITINIB MALATESUNITINIB MALATE
003CAPSULE;ORALEQ 37.5MG BASE0SUNITINIB MALATESUNITINIB MALATE
004CAPSULE;ORALEQ 50MG BASE0SUNITINIB MALATESUNITINIB MALATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213914
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 12.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-16
        )

)

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