BAXTER HLTHCARE CORP FDA Approval ANDA 076791

ANDA 076791

BAXTER HLTHCARE CORP

FDA Drug Application

Application #076791

Documents

Letter2008-01-09

Application Sponsors

ANDA 076791BAXTER HLTHCARE CORP

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 5MG BASE/ML0HALOPERIDOLHALOPERIDOL LACTATE

FDA Submissions

ORIG1AP2004-08-25
LABELING; LabelingSUPPL4AP2007-12-31
LABELING; LabelingSUPPL5AP2008-04-28
LABELING; LabelingSUPPL8AP2008-08-19
LABELING; LabelingSUPPL9AP2010-12-03
LABELING; LabelingSUPPL10AP2011-10-19

Submissions Property Types

SUPPL9Null7
SUPPL10Null15

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76791
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HALOPERIDOL","submission":"HALOPERIDOL LACTATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.