An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050823
Company: B BRAUN

Summary Review

Products on NDA 050823

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	EQ 1GM BASE	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	EQ 2GM BASE	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050823

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050823s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823_ceftazidime_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050823s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050823Orig1s009ltr.pdf
07/29/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050823Orig1s007ltr.pdf
05/15/2015	SUPPL-4	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/2015/050823s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050823Orig1s004ltr.pdf
04/01/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050823

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050823s009lbl.pdf
07/29/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf
05/15/2015	SUPPL-4	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/2015/050823s004lbl.pdf

Top