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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065204
Company: SANDOZ INC

Other Important Information from FDA

Products on ANDA 065204

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2005	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-28	Labeling-Package Insert		Label is not available on this site.
09/11/2020	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/13/2011	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/31/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/14/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065204

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065329	ACS DOBFAR
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065204	SANDOZ INC
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065180	WOCKHARDT
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050796	B BRAUN

INJECTABLE;INJECTION; EQ 2GM 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 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065329	ACS DOBFAR
CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065204	SANDOZ INC
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050796	B BRAUN

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