ANDA 089370

IDT AUSTRALIA LTD

FDA Drug Application

Application #089370

Application Sponsors

ANDA 089370

IDT AUSTRALIA LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-01-09
LABELING; Labeling	SUPPL	6	AP	1988-11-29
LABELING; Labeling	SUPPL	7	AP	1989-01-23
LABELING; Labeling	SUPPL	9	AP	1992-01-07

CDER Filings

IDT AUSTRALIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89370
            [companyName] => IDT AUSTRALIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)