Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050560
Company: ASTELLAS

Products on NDA 050560

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFIZOX	CEFTIZOXIME SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEFIZOX	CEFTIZOXIME SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEFIZOX	CEFTIZOXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CEFIZOX	CEFTIZOXIME SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1983	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2000	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
01/14/2005	SUPPL-51	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf
02/13/1996	SUPPL-50	Labeling		Label is not available on this site.
12/14/1995	SUPPL-49	Labeling		Label is not available on this site.
07/10/1995	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
03/19/1993	SUPPL-46	Labeling		Label is not available on this site.
01/22/1992	SUPPL-43	Labeling		Label is not available on this site.
05/05/1989	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1992	SUPPL-36	Efficacy-New Indication		Label is not available on this site.
04/29/1987	SUPPL-33	Manufacturing (CMC)-Expiration Date		Label is not available on this site.