ANDA 083347

IMPAX LABS

FDA Drug Application

Application #083347

Application Sponsors

ANDA 083347

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

QUINIDINE SULFATE

QUINIDINE SULFATE

FDA Submissions

	ORIG	1	AP	1976-12-08
LABELING; Labeling	SUPPL	26	AP	2001-02-21
LABELING; Labeling	SUPPL	27	AP	1988-11-23
LABELING; Labeling	SUPPL	28	AP	1988-12-23
LABELING; Labeling	SUPPL	29	AP	1990-02-28
LABELING; Labeling	SUPPL	30	AP	1990-02-28

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83347
            [companyName] => IMPAX LABS
            [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
        )

)