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Details for New Drug Application (NDA): 061334

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NDA 061334 describes BACTOCILL, which is a drug marketed by Glaxosmithkline and Baxter Hlthcare and is included in six NDAs. Additional details are available on the BACTOCILL profile page.

The generic ingredient in BACTOCILL 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 NDA: 061334

Tradename:
BACTOCILL
Applicant:
Glaxosmithkline
Ingredient:
oxacillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 26, 1982TE:RLD:No

Summary for product number 007

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 26, 1982TE:RLD:No

Summary for product number 008

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 26, 1982TE:RLD:No


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