SAGENT PHARMS INC FDA Approval ANDA 090109

ANDA 090109

SAGENT PHARMS INC

FDA Drug Application

Application #090109

Application Sponsors

ANDA 090109SAGENT PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 150MG BASE/ML0CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATE

FDA Submissions

ORIG1AP2011-09-30
LABELING; LabelingSUPPL7AP2018-04-16STANDARD
LABELING; LabelingSUPPL8AP2018-04-16STANDARD
LABELING; LabelingSUPPL11AP2018-04-16STANDARD
LABELING; LabelingSUPPL12AP2018-04-16STANDARD
LABELING; LabelingSUPPL13AP2021-02-09STANDARD
LABELING; LabelingSUPPL15AP2021-02-09STANDARD
LABELING; LabelingSUPPL16AP2021-02-09STANDARD

Submissions Property Types

ORIG1Null15
SUPPL7Null15
SUPPL8Null7
SUPPL11Null15
SUPPL12Null15
SUPPL13Null15
SUPPL15Null15
SUPPL16Null7

TE Codes

001PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90109
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 150MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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