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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 061490

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NDA 061490 describes OXACILLIN SODIUM, which is a drug marketed by Ani Pharms, Apothecon, Teva, Elkins Sinn, Eugia Pharma Speclts, Fresenius Kabi Usa, Hospira, Istituto Bio Ita Spa, Onesource Specialty, Piramal Critical, Sagent Pharms, Sandoz, Watson Labs Inc, and Wockhardt Bio Ag, and is included in twenty-three NDAs. It is available from six suppliers. Additional details are available on the OXACILLIN SODIUM profile page.

The generic ingredient in OXACILLIN SODIUM is oxacillin sodium. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.

Summary for 061490

Tradename:	OXACILLIN SODIUM
Applicant:	Sandoz
Ingredient:	oxacillin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 061490

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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