ANDA 078698

HIKMA FARMACEUTICA

FDA Drug Application

Application #078698

Application Sponsors

ANDA 078698

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	0	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE
002	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	0	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE

FDA Submissions

	ORIG	1	AP	2012-01-30
LABELING; Labeling	SUPPL	4	AP	2015-03-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78698
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"400MG\/200ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"400MG\/200ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)