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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091613

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NDA 091613 describes NAFCILLIN SODIUM, which is a drug marketed by Antibiotice, Apothecon, Aurobindo Pharma Ltd, Istituto Bio Ita Spa, Mylan Labs Ltd, Sagent Pharms, Sandoz, and Watson Labs Inc, and is included in thirteen NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the nafcillin sodium profile page.

Summary for 091613

Tradename:	NAFCILLIN SODIUM
Applicant:	Aurobindo Pharma Ltd
Ingredient:	nafcillin sodium
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 091613

Ingredient-type	Penicillins

Medical Subject Heading (MeSH) Categories for 091613

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 091613

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	091613	ANDA	AuroMedics Pharma LLC	55150-122	N	55150-122-15
NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	091613	ANDA	AuroMedics Pharma LLC	55150-123	N	55150-123-16

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Dec 26, 2012	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Dec 26, 2012	TE:	AP	RLD:	No

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