SAGENT PHARMS INC FDA Approval ANDA 091493

ANDA 091493

SAGENT PHARMS INC

FDA Drug Application

Application #091493

Application Sponsors

ANDA 091493SAGENT PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUSEQ 4MG BASE/5ML0ZOLEDRONIC ACIDZOLEDRONIC ACID

FDA Submissions

ORIG1AP2014-11-24
LABELING; LabelingSUPPL4AP2015-09-03STANDARD
LABELING; LabelingSUPPL5AP2020-12-21STANDARD
LABELING; LabelingSUPPL6AP2020-12-21STANDARD
LABELING; LabelingSUPPL7AP2020-12-21STANDARD
LABELING; LabelingSUPPL8AP2020-12-21STANDARD

Submissions Property Types

ORIG1Null17
SUPPL4Null15
SUPPL5Null7
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15

TE Codes

001PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91493
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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