BRISTOL MYERS SQUIBB FDA Approval NDA 020906

NDA 020906

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020906

Documents

Letter2002-11-05
Letter1998-02-27
Review1998-02-27

Application Sponsors

NDA 020906BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0ETOPOPHOS PRESERVATIVE FREEETOPOSIDE PHOSPHATE
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0ETOPOPHOS PRESERVATIVE FREEETOPOSIDE PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1998-02-27STANDARD
LABELING; LabelingSUPPL2AP2002-11-05STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20906
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETOPOPHOS PRESERVATIVE FREE","activeIngredients":"ETOPOSIDE PHOSPHATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ETOPOPHOS PRESERVATIVE FREE","activeIngredients":"ETOPOSIDE PHOSPHATE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETOPOPHOS PRESERVATIVE FREE","submission":"ETOPOSIDE PHOSPHATE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ETOPOPHOS PRESERVATIVE FREE","submission":"ETOPOSIDE PHOSPHATE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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