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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 050195


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NDA 050195 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 Speclts, 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 050195
Tradename:OXACILLIN SODIUM
Applicant:Apothecon
Ingredient:oxacillin sodium
Patents:0
Medical Subject Heading (MeSH) Categories for 050195

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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