Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065328
Company: ACS DOBFAR

• Other Important Information from FDA

Products on ANDA 065328

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2008	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-16	Labeling-Package Insert		Label is not available on this site.
03/02/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/26/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/22/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/04/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/24/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/30/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/04/2010	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
01/04/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
12/29/2009	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.
10/26/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065328

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