ANDA 083808

CONTRACT PHARMACAL

FDA Drug Application

Application #083808

Application Sponsors

ANDA 083808

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

QUINIDINE SULFATE

QUINIDINE SULFATE

FDA Submissions

	ORIG	1	AP	1977-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1985-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-09-20
LABELING; Labeling	SUPPL	21	AP	1989-10-13

Submissions Property Types

SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83808
            [companyName] => CONTRACT PHARMACAL
            [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
        )

)