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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050779
Company: B BRAUN

Products on NDA 050779

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050779

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
10/08/2021	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050779s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050779Orig1s031ltr.pdf
11/23/2020	SUPPL-27	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050779s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050779Orig1s027ltr.pdf
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	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050779s011lbl.pdf 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.

Labels for NDA 050779

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/08/2021	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050779s031lbl.pdf
11/23/2020	SUPPL-27	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050779s027lbl.pdf
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
10/31/2008	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050779s011lbl.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

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