SAGENT PHARMS INC FDA Approval ANDA 209110

ANDA 209110

SAGENT PHARMS INC

FDA Drug Application

Application #209110

Application Sponsors

ANDA 209110SAGENT PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2017-10-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209110
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-26
        )

)

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