ANDA 089371

IDT AUSTRALIA LTD

FDA Drug Application

Application #089371

Application Sponsors

ANDA 089371

IDT AUSTRALIA LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

750MG

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-08-14
LABELING; Labeling	SUPPL	2	AP	1989-01-23
LABELING; Labeling	SUPPL	3	AP	1992-01-07

CDER Filings

IDT AUSTRALIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89371
            [companyName] => IDT AUSTRALIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)