ANDA 075912

HAVIX

FDA Drug Application

Application #075912

Application Sponsors

ANDA 075912

HAVIX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

	ORIG	1	AP	2002-01-10
LABELING; Labeling	SUPPL	2	AP	2004-01-26
LABELING; Labeling	SUPPL	8	AP	2017-10-25	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-10-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-11-15	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HAVIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75912
            [companyName] => HAVIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOCONAZOLE","submission":"KETOCONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)