HOSPIRA FDA Approval ANDA 089703

ANDA 089703

HOSPIRA

FDA Drug Application

Application #089703

Application Sponsors

ANDA 089703HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 5MG BASE/ML0PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATE

FDA Submissions

ORIG1AP1988-04-07
LABELING; LabelingSUPPL2AP1989-06-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1989-07-06
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1990-11-30
LABELING; LabelingSUPPL5AP1991-02-01
LABELING; LabelingSUPPL7AP1993-07-29
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-07-29
LABELING; LabelingSUPPL9AP1993-06-22
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-08-17
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1998-08-17
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1999-12-10
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-05-24
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-02-14

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89703
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCHLORPERAZINE EDISYLATE","activeIngredients":"PROCHLORPERAZINE EDISYLATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCHLORPERAZINE EDISYLATE","submission":"PROCHLORPERAZINE EDISYLATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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