An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091048
Company: SAGENT PHARMS INC

Products on ANDA 091048

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 091048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/2017	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
05/21/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/15/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091048

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

Top