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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091246


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NDA 091246 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, Piramal Critical, Sagent Pharms, Sandoz, Steriscience, Watson Labs Inc, and Wockhardt Bio Ag, and is included in twenty-three NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the oxacillin sodium profile page.
Summary for 091246
Tradename:OXACILLIN SODIUM
Applicant:Sagent Pharms
Ingredient:oxacillin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091246
Medical Subject Heading (MeSH) Categories for 091246
Suppliers and Packaging for NDA: 091246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 091246 ANDA Sagent Pharmaceuticals 25021-146 25021-146-10 10 VIAL in 1 CARTON (25021-146-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
OXACILLIN SODIUM oxacillin sodium INJECTABLE;INJECTION 091246 ANDA Sagent Pharmaceuticals 25021-162 25021-162-24 10 VIAL in 1 CARTON (25021-162-24) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Mar 30, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Mar 30, 2012TE:APRLD:No

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