ANDA 089438

ANI PHARMS INC

FDA Drug Application

Application #089438

Application Sponsors

ANDA 089438

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

750MG

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-03-23
LABELING; Labeling	SUPPL	2	AP	1991-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-02-22
LABELING; Labeling	SUPPL	4	AP	1991-12-30
LABELING; Labeling	SUPPL	5	AP	1991-11-13
LABELING; Labeling	SUPPL	6	AP	1991-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-06-25
LABELING; Labeling	SUPPL	8	AP	1995-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-12-09
LABELING; Labeling	SUPPL	17	AP	2002-01-04
LABELING; Labeling	SUPPL	18	AP	2002-03-13

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	1
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89438
            [companyName] => ANI PHARMS INC
            [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
        )

)