SAGENT PHARMS INC FDA Approval ANDA 203323

ANDA 203323

SAGENT PHARMS INC

FDA Drug Application

Application #203323

Application Sponsors

ANDA 203323SAGENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 250MG BASE/ML0AMIKACIN SULFATEAMIKACIN SULFATE
002INJECTABLE;INJECTION500MG(BASE)/ML(250MG/ML)2AMIKACIN SULFATEAMIKACIN SULFATE
003INJECTABLE;INJECTION1G(BASE)/4ML(250MG/ML)2AMIKACIN SULFATEAMIKACIN SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2016-05-12

Submissions Property Types

ORIG1Null1
SUPPL12Null0

TE Codes

001PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203323
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 250MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"500MG(BASE)\/ML(250MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"1G(BASE)\/4ML(250MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/12\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-New Strength","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-05-12
        )

)

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