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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064125
Company: ACS DOBFAR SPA

Products on ANDA 064125

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	AB	No	No
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064125

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/1997	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
10/08/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/12/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/21/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/31/2007	SUPPL-5	Labeling		Label is not available on this site.
08/23/2004	SUPPL-3	Labeling		Label is not available on this site.
09/23/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064125

CEFUROXIME SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AB	064125	ACS DOBFAR SPA
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AB	065048	HIKMA

INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064125	ACS DOBFAR SPA
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065048	HIKMA

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