ANDA 076828

BAXTER HLTHCARE CORP

FDA Drug Application

Application #076828

Documents

• Letter: 2008-01-09

Application Sponsors

ANDA 076828

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

HALOPERIDOL

HALOPERIDOL LACTATE

FDA Submissions

	ORIG	1	AP	2004-08-25
LABELING; Labeling	SUPPL	3	AP	2007-12-31
LABELING; Labeling	SUPPL	4	AP	2008-04-28
LABELING; Labeling	SUPPL	7	AP	2010-12-03
LABELING; Labeling	SUPPL	8	AP	2011-10-19

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76828
            [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
        )

)