SAGENT PHARMS INC FDA Approval ANDA 208674

ANDA 208674

SAGENT PHARMS INC

FDA Drug Application

Application #208674

Application Sponsors

ANDA 208674SAGENT PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 2GM BASE/VIAL; EQ 250MG BASE/VIAL0PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUM
002INJECTABLE;INJECTIONEQ 3GM BASE/VIAL; EQ 375MG BASE/VIAL0PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUM
003INJECTABLE;INJECTIONEQ 4GM BASE/VIAL; EQ 500MG BASE/VIAL0PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-02-16STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208674
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL; EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 3GM BASE\/VIAL; EQ 375MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 4GM BASE\/VIAL; EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-16
        )

)

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