ANDA 083862

HIKMA PHARMS

FDA Drug Application

Application #083862

Application Sponsors

ANDA 083862

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

QUINIDINE SULFATE

QUINIDINE SULFATE

FDA Submissions

	ORIG	1	AP	1976-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1984-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-01-07

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83862
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE SULFATE","activeIngredients":"QUINIDINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINIDINE SULFATE","submission":"QUINIDINE SULFATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)