FDA.reportPublic FDA data

Application 050679

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAXIPIMECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALYesYes
002MAXIPIMECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesYes
003MAXIPIMECEFEPIME HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0217MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0217MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0217MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0218MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0218MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0219MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0219MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0220MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0220MAXIPIMECefepimeHospira, Inc.NDACurrent
0409-0220MAXIPIMECefepimeHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68356SUPPL2021-08-12
68349SUPPL2021-08-12
48290SUPPL2017-05-09
48243SUPPL2017-05-05
39102SUPPL2016-03-03
7983SUPPL2016-03-03
30263SUPPL2014-05-06
39099SUPPL2014-05-02
39101SUPPL2013-03-19
30264SUPPL2013-03-18
18006SUPPL2012-09-11
7982SUPPL2012-09-10
7981SUPPL2009-11-20
39100SUPPL2009-09-30
44202ORIG2007-12-17
30262SUPPL2007-11-26
39098SUPPL2007-09-19
18005SUPPL2004-06-10
7980SUPPL2004-06-10
39097SUPPL2003-03-26
7979SUPPL2003-03-26
30261SUPPL2002-08-21
7978SUPPL2002-08-21
7977SUPPL2002-08-21
42673SUPPL2001-07-18
39096SUPPL1999-01-27
7976SUPPL1999-01-27
22181SUPPL1997-05-16
57440ORIG1996-01-18