Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050779
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription 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
07/27/2000 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50779ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50779_Cefazolin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2015 SUPPL-25 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/2015/050779s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050779Orig1s025ltr.pdf
09/18/2014 SUPPL-23 Efficacy-Pediatric Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050779Orig1s023ltr.pdf
08/21/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/11/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/10/2012 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/23/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s019ltr.pdf
01/13/2012 SUPPL-18 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s018ltr.pdf
09/10/2007 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050779s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050779s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050779s013ltr.pdf
10/31/2008 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050779s011ltr.pdf
05/06/2005 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050779s006ltr.pdf
06/29/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50779slr005_cefazolin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50779slr005ltr.pdf
06/01/2001 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/08/2015 SUPPL-25 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/2015/050779s025lbl.pdf
04/23/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s019lbl.pdf
01/13/2012 SUPPL-18 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf
09/10/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050779s013lbl.pdf
06/29/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50779slr005_cefazolin_lbl.pdf
07/27/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English