Details for New Drug Application (NDA): 206198

NDA 206198 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 206198

Tradename:	OXACILLIN SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	oxacillin sodium
Patents:	0

Pharmacology for NDA: 206198

Medical Subject Heading (MeSH) Categories for 206198

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 206198

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXACILLIN SODIUM	oxacillin sodium	INJECTABLE;INJECTION	206198	ANDA	Fresenius Kabi USA, LLC	63323-812	63323-812-20	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-812-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-812-01)
OXACILLIN SODIUM	oxacillin sodium	INJECTABLE;INJECTION	206198	ANDA	Fresenius Kabi USA, LLC	63323-813	63323-813-20	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-813-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-813-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jul 20, 2020	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Jul 20, 2020	TE:	AP	RLD:	No

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