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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065168
Company: SANDOZ

Other Important Information from FDA

Products on ANDA 065168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2005	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
01/13/2022	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/31/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf
02/17/2012	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/23/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/14/2009	SUPPL-5	Labeling		Label is not available on this site.

Labels for ANDA 065168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf

Therapeutic Equivalents for ANDA 065168

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065328	ACS DOBFAR
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209218	QILU
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065168	SANDOZ
CEFTRIAXONE SODIUM	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091117	ANDA REPOSITORY
CEFTRIAXONE SODIUM	CEFTRIAXONE SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090701	HIKMA

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