Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065263
Company: LUPIN

• Other Important Information from FDA

Products on ANDA 065263

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2006	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
05/27/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/27/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/27/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/02/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/06/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/02/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/11/2008	SUPPL-3	Labeling		Label is not available on this site.