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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/11/2021 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050679s046lbl.pdf
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

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