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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 065214
Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM 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
03/10/2006 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2019 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/065214s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/065214Orig1s016ltr.pdf
06/05/2013 SUPPL-13 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/2013/065214s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065214Orig1s013ltr.pdf
12/12/2012 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
02/22/2010 SUPPL-8 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf
01/07/2008 SUPPL-5 Labeling

Label is not available on this site.
02/04/2010 SUPPL-2 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/29/2019 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/065214s016lbl.pdf
06/05/2013 SUPPL-13 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/2013/065214s013lbl.pdf
02/22/2010 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf
02/04/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER

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
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065414 ACS DOBFAR
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065051 HIKMA
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 065214 B BRAUN

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
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065414 ACS DOBFAR
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065051 HIKMA
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 065214 B BRAUN
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