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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 091048

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NDA 091048 describes CEFEPIME HYDROCHLORIDE, which is a drug marketed by Acs Dobfar, Astral, Chartwell Rx, Hikma, Hospira Inc, Qilu Antibiotics, Sagent Pharms Inc, and Samson Medcl, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the CEFEPIME HYDROCHLORIDE profile page.

The generic ingredient in CEFEPIME HYDROCHLORIDE is cefepime hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

Summary for 091048

Tradename:	CEFEPIME HYDROCHLORIDE
Applicant:	Sagent Pharms Inc
Ingredient:	cefepime hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jan 4, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Jan 4, 2017	TE:	AP	RLD:	No

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