ANDA 089537

HOSPIRA

FDA Drug Application

Application #089537

Application Sponsors

ANDA 089537

HOSPIRA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

500MG/ML

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-11-30
LABELING; Labeling	SUPPL	4	AP	1992-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-02-14

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	1
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89537
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"500MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)