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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214402
Company: HIKMA

Products on ANDA 214402

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 214402

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214402

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	214402	HIKMA
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203704	QILU ANTIBIOTICS
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	214402	HIKMA
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203704	QILU ANTIBIOTICS
CEFEPIME HYDROCHLORIDE	CEFEPIME HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091048	SAGENT PHARMS INC

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