ANDA 088958

ANI PHARMS INC

FDA Drug Application

Application #088958

Application Sponsors

ANDA 088958

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

250MG

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-06-05
LABELING; Labeling	SUPPL	6	AP	1989-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-09-03
LABELING; Labeling	SUPPL	11	AP	1992-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-05-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88958
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)