ANDA 089522

HOSPIRA

FDA Drug Application

Application #089522

Application Sponsors

ANDA 089522

HOSPIRA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10,000 UNITS/ML

0

HEPARIN SODIUM PRESERVATIVE FREE

HEPARIN SODIUM

FDA Submissions

	ORIG	1	AP	1987-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-03-14
LABELING; Labeling	SUPPL	3	AP	1991-02-22
LABELING; Labeling	SUPPL	4	AP	1992-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-04-06
LABELING; Labeling	SUPPL	7	AP	1993-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-08-10
LABELING; Labeling	SUPPL	14	AP	1998-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-02-14
LABELING; Labeling	SUPPL	30	AP	2008-10-28
LABELING; Labeling	SUPPL	33	AP	2009-05-08
LABELING; Labeling	SUPPL	35	AP	2010-01-19
LABELING; Labeling	SUPPL	36	AP	2010-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2014-05-29
LABELING; Labeling	SUPPL	44	AP	2012-11-23	STANDARD
LABELING; Labeling	SUPPL	47	AP	2013-05-06	STANDARD
LABELING; Labeling	SUPPL	56	AP	2020-08-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	35	Null	7
SUPPL	36	Null	7
SUPPL	43	Null	15
SUPPL	44	Null	15
SUPPL	47	Null	15
SUPPL	56	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89522
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM PRESERVATIVE FREE","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEPARIN SODIUM PRESERVATIVE FREE","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)