ANDA 076736

HIKMA FARMACEUTICA

FDA Drug Application

Application #076736

Application Sponsors

ANDA 076736

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/100ML (2MG/ML)

0

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

FLUCONAZOLE

FDA Submissions

	ORIG	1	AP	2005-08-23
LABELING; Labeling	SUPPL	6	AP	2008-08-29
LABELING; Labeling	SUPPL	8	AP	2010-11-30
LABELING; Labeling	SUPPL	9	AP	2012-01-25
LABELING; Labeling	SUPPL	13	AP	2015-03-19	STANDARD

Submissions Property Types

SUPPL	9	Null	15
SUPPL	13	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76736
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9%","activeIngredients":"FLUCONAZOLE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9%","submission":"FLUCONAZOLE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)