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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065441
Company: ACS DOBFAR

Other Important Information from FDA

Products on ANDA 065441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2008	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
01/03/2022	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
05/25/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
05/25/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/25/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/25/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/25/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/26/2013	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/29/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065441

CEFEPIME HYDROCHLORIDE

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
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065441	ACS DOBFAR
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203704	QILU
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091048	SAGENT PHARMS INC

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065441	ACS DOBFAR
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203704	QILU
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091048	SAGENT PHARMS INC

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