Details for New Drug Application (NDA): 050817

NDA 050817 describes CEFEPIME IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CEFEPIME IN PLASTIC CONTAINER profile page.

The generic ingredient in CEFEPIME IN PLASTIC CONTAINER 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 050817

Tradename:	CEFEPIME IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare
Ingredient:	cefepime hydrochloride
Patents:	0

Pharmacology for NDA: 050817

Suppliers and Packaging for NDA: 050817

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301	0338-1301-41	24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG
CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301	0338-1301-48	12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Approval Date:	Aug 5, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
Approval Date:	Aug 5, 2008	TE:		RLD:	Yes

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