ANDA 078527

HIKMA FARMACEUTICA

FDA Drug Application

Application #078527

Application Sponsors

ANDA 078527

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

ORIG

1

AP

2009-03-23

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78527
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUMAZENIL","activeIngredients":"FLUMAZENIL","strength":"0.5MG\/5ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUMAZENIL","activeIngredients":"FLUMAZENIL","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUMAZENIL","submission":"FLUMAZENIL","actionType":"0.5MG\/5ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUMAZENIL","submission":"FLUMAZENIL","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)