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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065048
Company: HIKMA

Products on ANDA 065048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFUROXIME	CEFUROXIME	1.5G/20ML	Injectable; Injection	Prescription	None	No	No
CEFUROXIME	CEFUROXIME	1.5G/100ML	Injectable; Injection	Prescription	None	No	No
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	AB	No	Yes
CEFUROXIME SODIUM	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2004	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
07/07/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
07/07/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/16/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/12/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
01/16/2008	SUPPL-8	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065048

CEFUROXIME

There are no Therapeutic Equivalents.

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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