Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050679
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/18/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050679Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050679s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050679Orig1s042ltr.pdf
06/22/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/01/2016 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf
03/04/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/06/2012 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf
03/15/2013 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf
09/30/2009 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf
05/01/2014 SUPPL-31 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf
09/14/2007 SUPPL-28 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf
09/14/2007 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf
06/09/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf
03/17/2003 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-021ltr.pdf
03/15/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
04/02/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/10/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/26/2000 SUPPL-15 Labeling

Label is not available on this site.

08/21/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
09/20/2000 SUPPL-13 Labeling

Label is not available on this site.

11/24/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/21/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1998 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
01/30/1998 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

01/27/1999 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine.cfm
02/08/1999 SUPPL-5 Labeling

Label is not available on this site.

10/20/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/23/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1997 SUPPL-2 Efficacy-New Indication Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050679s002.cfm
03/13/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2017 SUPPL-42 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050679s042lbl.pdf
03/01/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf
05/01/2014 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf
05/01/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf
03/15/2013 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf
09/06/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf
09/30/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf
09/14/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf
06/09/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf
03/17/2003 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf
01/27/1999 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf

MAXIPIME

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065441 ACS DOBFAR
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091048 SAGENT PHARMS INC
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065441 ACS DOBFAR
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091048 SAGENT PHARMS INC
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC

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