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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050517
Company: MYLAN INSTITUTIONAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEFOXIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
MEFOXIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
MEFOXIN CEFOXITIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/18/1978 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2017 SUPPL-53 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/2017/050517s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050517Orig1s053ltr.pdf
05/10/2013 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050517Orig1s051ltr.pdf
02/04/2011 SUPPL-50 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050517s050ltr.pdf
09/17/2007 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050517s047ltr.pdf
06/02/2004 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr046ltr.pdf
06/28/2004 SUPPL-45 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf
06/06/2002 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.
05/07/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.
06/28/2004 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf
10/19/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
10/12/1999 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.
04/24/1997 SUPPL-39 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517S039_Mefoxin.pdf
02/14/2000 SUPPL-38 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-517s038_Mefoxin.cfm
10/11/1996 SUPPL-37 Labeling

Label is not available on this site.
11/30/1994 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1996 SUPPL-35 Labeling

Label is not available on this site.
10/27/1994 SUPPL-33 Labeling

Label is not available on this site.
05/20/1996 SUPPL-32 Labeling

Label is not available on this site.
02/27/1997 SUPPL-31 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517s031_50-581s020_Mefoxin.cfm
02/28/1995 SUPPL-29 Efficacy-New Dosing Regimen

Label is not available on this site.
07/30/1996 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/09/2017 SUPPL-53 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/2017/050517s053lbl.pdf
05/10/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf
09/17/2007 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf
06/02/2004 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf
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