SAGENT PHARMS INC FDA Approval ANDA 205871

ANDA 205871

SAGENT PHARMS INC

FDA Drug Application

Application #205871

Application Sponsors

ANDA 205871SAGENT PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR50MG/ML0FULVESTRANTFULVESTRANT

FDA Submissions

UNKNOWN; ORIG1AP2019-08-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAO

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205871
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-22
        )

)

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