ANDA 076813

HIKMA INTL PHARMS

FDA Drug Application

Application #076813

Application Sponsors

ANDA 076813

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	60MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
002	TABLET, EXTENDED RELEASE;ORAL	30MG	0	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE

FDA Submissions

	ORIG	1	AP	2005-01-07
LABELING; Labeling	SUPPL	2	AP	2006-03-30
LABELING; Labeling	SUPPL	12	AP	2015-11-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	12	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76813
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ISOSORBIDE MONONITRATE","activeIngredients":"ISOSORBIDE MONONITRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE MONONITRATE","submission":"ISOSORBIDE MONONITRATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ISOSORBIDE MONONITRATE","submission":"ISOSORBIDE MONONITRATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)