HOSPIRA INC FDA Approval NDA 050679

Application #050679

Documents

Letter	1999-01-27
Letter	2002-08-21
Letter	2002-08-21
Letter	2003-03-26
Letter	2004-06-10
Letter	2009-11-20
Letter	2012-09-10
Letter	2016-03-03
Label	2004-06-10
Label	2012-09-11
Review	1997-05-16
Letter	2002-08-21
Letter	2007-11-26
Letter	2014-05-06
Letter	2013-03-18
Label	1999-01-27
Label	2003-03-26
Label	2007-09-19
Label	2014-05-02
Label	2009-09-30
Label	2013-03-19
Label	2016-03-03
Review	2001-07-18
Other Important Information from FDA	2007-12-17
Label	2017-05-05
Letter	2017-05-09
Review	1996-01-18
Label	2021-08-12
Letter	2021-08-12

Application Sponsors

NDA 050679

HOSPIRA INC

Marketing Status

Prescription	001
Prescription	002
Prescription	003

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	1	MAXIPIME	CEFEPIME HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	1	MAXIPIME	CEFEPIME HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	1	MAXIPIME	CEFEPIME HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1997-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-10-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	1999-02-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	1999-01-27	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	1998-01-30	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-11-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2000-09-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-08-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2000-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-04-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-03-15	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	2003-03-17	STANDARD
LABELING; Labeling	SUPPL	23	AP	2004-06-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2007-09-14	STANDARD
LABELING; Labeling	SUPPL	28	AP	2007-09-14	STANDARD
LABELING; Labeling	SUPPL	31	AP	2014-05-01	STANDARD
LABELING; Labeling	SUPPL	32	AP	2009-09-30	STANDARD
LABELING; Labeling	SUPPL	34	AP	2013-03-15	UNKNOWN
LABELING; Labeling	SUPPL	36	AP	2012-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2014-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2016-03-04	STANDARD
LABELING; Labeling	SUPPL	40	AP	2016-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2016-06-22	STANDARD
LABELING; Labeling	SUPPL	42	AP	2017-05-03	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	46	AP	2021-08-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	9
SUPPL	24	Null	0
SUPPL	31	Null	6
SUPPL	32	Null	7
SUPPL	34	Null	7
SUPPL	36	Null	7
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	15
SUPPL	41	Null	0
SUPPL	42	Null	6
SUPPL	46	Null	6

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50679
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAXIPIME","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MAXIPIME","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MAXIPIME","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/03\/2017","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050679s042lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/01\/2016","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050679s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2014","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050679s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050679s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2013","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050679s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050679s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050679s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2007","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050679s028lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50679slr023_maxipime_lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2003","submission":"SUPPL-21","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50679se2-021_maxipime_lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/1999","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/50679S007_Maxipine_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MAXIPIME","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MAXIPIME","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MAXIPIME","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-05-03
        )

)

NDA 050679

HOSPIRA INC

FDA Drug Application

Application #050679

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

HOSPIRA INC