ANDA 075695

BAXTER HLTHCARE CORP

FDA Drug Application

Application #075695

Application Sponsors

ANDA 075695

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	1MG/ML	0	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE
002	INJECTABLE;INJECTION	2MG/ML	0	BUTORPHANOL TARTRATE PRESERVATIVE FREE	BUTORPHANOL TARTRATE

FDA Submissions

	ORIG	1	AP	2001-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2008-05-16
LABELING; Labeling	SUPPL	21	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-10-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75695
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTORPHANOL TARTRATE PRESERVATIVE FREE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BUTORPHANOL TARTRATE PRESERVATIVE FREE","activeIngredients":"BUTORPHANOL TARTRATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTORPHANOL TARTRATE PRESERVATIVE FREE","submission":"BUTORPHANOL TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BUTORPHANOL TARTRATE PRESERVATIVE FREE","submission":"BUTORPHANOL TARTRATE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)