Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065306
Company: ACS DOBFAR

Products on ANDA 065306

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 20GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065306

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2008	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
12/02/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/13/2013	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
08/18/2014	SUPPL-3	Manufacturing (CMC)-New Strength		Label is not available on this site.
05/26/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
07/20/2010	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 065306

CEFAZOLIN SODIUM

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 ANTIBIOTICS
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062831	SANDOZ