ANDA 076755

BAXTER HLTHCARE CORP

FDA Drug Application

Application #076755

Application Sponsors

ANDA 076755

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	0	FLUMAZENIL	FLUMAZENIL
002	INJECTABLE;INJECTION	0.5MG/5ML (0.1MG/ML)	0	FLUMAZENIL	FLUMAZENIL

FDA Submissions

	ORIG	1	AP	2004-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-08-26	UNKNOWN

Submissions Property Types

SUPPL

13

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76755
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUMAZENIL","activeIngredients":"FLUMAZENIL","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUMAZENIL","activeIngredients":"FLUMAZENIL","strength":"0.5MG\/5ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUMAZENIL","submission":"FLUMAZENIL","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUMAZENIL","submission":"FLUMAZENIL","actionType":"0.5MG\/5ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)