Details for New Drug Application (NDA): 090002

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NDA 090002 describes NAFCILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Eugia Pharma Speclts, Fresenius, Istituto Bio Ita Spa, Onesource Specialty, Sagent Pharms, Sandoz, Steriscience, and Watson Labs Inc, and is included in sixteen 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 is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for 090002

Tradename:	NAFCILLIN SODIUM
Applicant:	Acs Dobfar Spa
Ingredient:	nafcillin sodium
Patents:	0

Pharmacology for NDA: 090002

Medical Subject Heading (MeSH) Categories for 090002

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 090002

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090002	ANDA	Fresenius Kabi USA, LLC	63323-327	63323-327-10	10 VIAL in 1 CARTON (63323-327-10) / 4 mL in 1 VIAL (63323-327-21)
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	090002	ANDA	Fresenius Kabi USA, LLC	63323-328	63323-328-20	10 VIAL in 1 CARTON (63323-328-20) / 8 mL in 1 VIAL (63323-328-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jun 30, 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:	Jun 30, 2011	TE:	AP	RLD:	No

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