ANDA 089219

ANI PHARMS INC

FDA Drug Application

Application #089219

Application Sponsors

ANDA 089219

ANI PHARMS INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	250MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE
002	CAPSULE;ORAL	375MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE
003	CAPSULE;ORAL	500MG	0	PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-07-14
LABELING; Labeling	SUPPL	4	AP	1988-10-20
LABELING; Labeling	SUPPL	5	AP	1991-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-01-24

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89219
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"375MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"375MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)