TheraRadar
Data updated: May 26, 2026

NAFCILLIN SODIUM

Infectious Disease Approved 1984-08-02

NAFCILLIN SODIUM is indicated for the treatment of Staphylococcal Infections.

Source: FDA Label • Fresenius Kabi
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
12
Indications
--
Phase 3 Trials
41
Years on Market

Details

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

Companies

Fresenius Kabi ISTITUTO BIO ITA SPA Novartis ANTIBIOTICE SAGENT PHARMS EUGIA PHARMA SPECLTS ONESOURCE SPECIALTY APOTHECON WATSON LABS INC
Active Ingredient: NAFCILLIN SODIUM

NAFCILLIN SODIUM Approval History

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Original
New Indication
New Form
Label Update
185 FDA actions from 1984 to 2022
Dec 2022 SUPPL
Label · Labeling
Feb 2021 SUPPL
Label · Labeling
Jan 2021 SUPPL
Label · Labeling

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

NAFCILLIN SODIUM Competitive Set

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Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

BACTOCILL IN PLASTIC CONTAINER
Baxter
1989 1 indic.
CLEOCIN PHOSPHATE
Pfizer
1972 10 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NAFCILLIN SODIUM

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BACTOCILL IN PLASTIC CONTAINER
OXACILLIN SODIUM
1 shared
Baxter
Shared indications:
Staphylococcal Infections
CLEOCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE
1 shared
Pfizer
Shared indications:
Staphylococcal Infections
LINCOCIN
LINCOMYCIN HYDROCHLORIDE
1 shared
PHARMACIA AND UPJOHN
Shared indications:
Staphylococcal Infections
View all 4 similar drugs Pro
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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

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

NAFCILLIN SODIUM is indicated for the treatment of Staphylococcal Infections.

Looking for the branded version?

NALLPEN IN PLASTIC CONTAINER

Full clinical data, patents, trials, and competitive landscape for nafcillin sodium.

See NALLPEN IN PLASTIC CONTAINER

Data Sources

FDA Approval: ANDA206761 → Label: DailyMed → Trials: ClinicalTrials.gov →

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