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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 062798

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NDA 062798 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 062798

Tradename:	OXACILLIN SODIUM
Applicant:	Istituto Bio Ita Spa
Ingredient:	oxacillin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 062798

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Dec 11, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Dec 11, 1995	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 125MG BASE/VIAL
Approval Date:	Dec 11, 1995	TE:		RLD:	No

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