Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065415
Company: ACS DOBFAR

Products on ANDA 065415

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2010	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
05/02/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065415

CEFOXITIN

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
CEFOXITIN	CEFOXITIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065415	ACS DOBFAR
CEFOXITIN	CEFOXITIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065050	HIKMA
CEFOXITIN	CEFOXITIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065239	HIKMA FARMACEUTICA