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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 212721

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NDA 212721 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 seven 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. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

Summary for 212721

Tradename:	CEFEPIME HYDROCHLORIDE
Applicant:	Astral
Ingredient:	cefepime hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jul 21, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Jul 21, 2020	TE:		RLD:	No

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