JIANGSU HANSOH PHARM FDA Approval ANDA 091106

ANDA 091106

JIANGSU HANSOH PHARM

FDA Drug Application

Application #091106

Application Sponsors

ANDA 091106JIANGSU HANSOH PHARM

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 10MG BASE/ML0VINORELBINE TARTRATEVINORELBINE TARTRATE

FDA Submissions

ORIG1AP2012-09-26
LABELING; LabelingSUPPL5AP2020-07-27STANDARD
LABELING; LabelingSUPPL7AP2020-07-27STANDARD
LABELING; LabelingSUPPL9AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null7
SUPPL5Null7
SUPPL7Null7
SUPPL9Null7

TE Codes

001PrescriptionAP

CDER Filings

JIANGSU HANSOH PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91106
            [companyName] => JIANGSU HANSOH PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"VINORELBINE TARTRATE","activeIngredients":"VINORELBINE TARTRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VINORELBINE TARTRATE","submission":"VINORELBINE TARTRATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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