Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050780
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 1.5GM 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
02/21/2001 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2015 SUPPL-19 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/2015/050780s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf
12/12/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/10/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf
05/06/2005 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf
06/29/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf
08/18/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2015 SUPPL-19 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/2015/050780s019lbl.pdf
09/10/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf
02/21/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER

INJECTABLE;INJECTION; EQ 750MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050780 B BRAUN

INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050780 B BRAUN
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064125 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065048 HIKMA FARMACEUTICA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065483 HOSPIRA INC
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065503 HOSPIRA INC
ZINACEF CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 TELIGENT

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