Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065230
Company: HOSPIRA INC

• Other Important Information from FDA

Products on ANDA 065230

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	No	No
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	No	No
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	No	No
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065230

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/31/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/27/2009	SUPPL-12	Labeling		Label is not available on this site.
08/27/2009	SUPPL-11	Labeling		Label is not available on this site.
11/14/2008	SUPPL-10	Labeling		Label is not available on this site.
11/14/2008	SUPPL-7	Labeling		Label is not available on this site.