ANDA 075697

BAXTER HLTHCARE CORP

FDA Drug Application

Application #075697

Application Sponsors

ANDA 075697

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE

FDA Submissions

	ORIG	1	AP	2001-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2008-06-12
LABELING; Labeling	SUPPL	13	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-10-11	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	7

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75697
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTORPHANOL TARTRATE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTORPHANOL TARTRATE","submission":"BUTORPHANOL TARTRATE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)