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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 201538

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NDA 201538 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 201538

Tradename:	OXACILLIN SODIUM
Applicant:	Eugia Pharma Speclts
Ingredient:	oxacillin sodium
Patents:	0

Pharmacology for NDA: 201538

Medical Subject Heading (MeSH) Categories for 201538

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201538

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXACILLIN SODIUM	oxacillin sodium	INJECTABLE;INJECTION	201538	ANDA	Eugia US LLC	55150-129	55150-129-99	1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-129-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Jan 18, 2013	TE:	AP	RLD:	No

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