Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063239
Company: HOFFMANN LA ROCHE

• Other Important Information from FDA

Products on ANDA 063239

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/1993	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
06/25/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/14/2006	SUPPL-5	Labeling		Label is not available on this site.
12/20/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/14/1994	SUPPL-1	Labeling		Label is not available on this site.