Details for New Drug Application (NDA): 090560

NDA 090560 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Sagent Pharms, Sandoz, Steriscience Speclts, and Watson Labs Inc, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the NAFCILLIN SODIUM profile page.

The generic ingredient in NAFCILLIN SODIUM is nafcillin sodium. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for 090560

Tradename:	NAFCILLIN SODIUM
Applicant:	Antibiotice
Ingredient:	nafcillin sodium
Patents:	0

Pharmacology for NDA: 090560

Medical Subject Heading (MeSH) Categories for 090560

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 090560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090560	ANDA	WG Critical Care, LLC	44567-221	44567-221-10	10 VIAL in 1 CARTON (44567-221-10) / 1 POWDER, FOR SOLUTION in 1 VIAL
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090560	ANDA	WG Critical Care, LLC	44567-222	44567-222-10	10 VIAL in 1 CARTON (44567-222-10) / 1 POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Oct 3, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Oct 3, 2011	TE:	AP	RLD:	No

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