SAGENT PHARMS INC FDA Approval ANDA 078373

ANDA 078373

SAGENT PHARMS INC

FDA Drug Application

Application #078373

Application Sponsors

ANDA 078373SAGENT PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION30MG/10ML (3MG/ML)0PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM
002INJECTABLE;INJECTION90MG/10ML (9MG/ML)0PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM

FDA Submissions

ORIG1AP2008-12-23
LABELING; LabelingSUPPL4AP2010-03-15
LABELING; LabelingSUPPL5AP2019-11-22STANDARD

Submissions Property Types

SUPPL4Null7
SUPPL5Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78373
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"30MG\/10ML (3MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"90MG\/10ML (9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"30MG\/10ML (3MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"90MG\/10ML (9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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