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Data updated: Mar 10, 2026

CEFOTAN

CEFOTETAN DISODIUM
Infectious Disease Approved 1985-12-27
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-27
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

PAI HOLDINGS PHARM TELIGENT
Active Ingredient: CEFOTETAN DISODIUM

CEFOTAN Approval History

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What CEFOTAN Treats

4 indications

CEFOTAN is approved for 4 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Lower Respiratory Tract Infection
  • Skin and Skin Structure Infection
  • Gynecologic Infection
Source: FDA Label

Drugs Similar to CEFOTAN

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ACHROMYCIN V
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AMPICILLIN SODIUM
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Shared indications:
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ANCOBON
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Shared indications:
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Shared indications:
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Active Pipeline

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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

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.

CEFOTAN FDA Label Details

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Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN ® and other antibacterial drugs, CEFOTAN ® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment CEFOTAN® (Cefotetan for Injection, USP) is indicated for the th...

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Data Sources

FDA Approval: NDA050588 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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