Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062831
Company: SANDOZ

Products on ANDA 062831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1988	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
06/24/2016	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
06/24/2016	SUPPL-33	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/15/2013	SUPPL-29	Labeling		Label is not available on this site.
02/12/2008	SUPPL-18	Labeling		Label is not available on this site.
06/01/2006	SUPPL-15	Labeling		Label is not available on this site.
03/05/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/25/1998	SUPPL-8	Labeling		Label is not available on this site.
11/25/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/16/1995	SUPPL-6	Labeling		Label is not available on this site.
09/25/1992	SUPPL-5	Labeling		Label is not available on this site.
07/17/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/18/1991	SUPPL-3	Labeling		Label is not available on this site.
12/15/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/15/1992	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062831

CEFAZOLIN SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065303	ACS DOBFAR
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065047	HIKMA FARMACEUTICA
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062831	SANDOZ

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
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065303	ACS DOBFAR
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065047	HIKMA FARMACEUTICA
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203661	QILU
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062831	SANDOZ
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065345	SANDOZ

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
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065306	ACS DOBFAR
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065143	HIKMA FARMACEUTICA
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	209217	QILU
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062831	SANDOZ