ANDA 089069

HOSPIRA

FDA Drug Application

Application #089069

Application Sponsors

ANDA 089069

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-02-12
LABELING; Labeling	SUPPL	2	AP	1988-11-23
LABELING; Labeling	SUPPL	3	AP	1988-08-12
LABELING; Labeling	SUPPL	4	AP	1991-01-28
LABELING; Labeling	SUPPL	5	AP	1991-08-13
LABELING; Labeling	SUPPL	6	AP	1991-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-08-24
LABELING; Labeling	SUPPL	10	AP	1998-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-06-08
LABELING; Labeling	SUPPL	13	AP	1998-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-06-08
LABELING; Labeling	SUPPL	16	AP	1999-05-05

Submissions Property Types

SUPPL	6	Null	1
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89069
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCAINAMIDE HYDROCHLORIDE","submission":"PROCAINAMIDE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)