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Data updated: Mar 10, 2026

NAFCILLIN SODIUM

NAFCILLIN SODIUM
Infectious Disease Approved 1984-08-02
12
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1984-08-02
Routes
INJECTION
Dosage Forms
INJECTABLE

NAFCILLIN SODIUM Approval History

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What NAFCILLIN SODIUM Treats

1 indications

NAFCILLIN SODIUM is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Staphylococcal Infections
Source: FDA Label
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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NAFCILLIN SODIUM FDA Label Details

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Indications & Usage

Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY โ€” Susceptibility Test Methods . Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection, USP should be d...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.