ANDA 078715

HIKMA INTL PHARMS

FDA Drug Application

Application #078715

Application Sponsors

ANDA 078715

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

300MG

0

LITHIUM CARBONATE

LITHIUM CARBONATE

FDA Submissions

	ORIG	1	AP	2010-12-28
LABELING; Labeling	SUPPL	3	AP	2012-03-06

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78715
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LITHIUM CARBONATE","submission":"LITHIUM CARBONATE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)