ANDA 089369

ANI PHARMS INC

FDA Drug Application

Application #089369

Application Sponsors

ANDA 089369

ANI PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	250MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	500MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	750MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-08-14
LABELING; Labeling	SUPPL	5	AP	1988-11-29
LABELING; Labeling	SUPPL	6	AP	1989-01-23
LABELING; Labeling	SUPPL	7	AP	1992-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-05-09

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89369
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"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":"250MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)