ANDA 076490

HIKMA INTL PHARMS

FDA Drug Application

Application #076490

Application Sponsors

ANDA 076490

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

450MG

0

LITHIUM CARBONATE

LITHIUM CARBONATE

FDA Submissions

	ORIG	1	AP	2003-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2007-06-19
LABELING; Labeling	SUPPL	3	AP	2007-10-05
LABELING; Labeling	SUPPL	10	AP	2018-12-06	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-02-05	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76490
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LITHIUM CARBONATE","submission":"LITHIUM CARBONATE","actionType":"450MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)