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Data updated: Mar 10, 2026

ERYTHROCIN

ERYTHROMYCIN LACTOBIONATE
Immunology Approved 1964-06-25
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1964-06-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Pfizer ABBOTT
Active Ingredient: ERYTHROMYCIN LACTOBIONATE

ERYTHROCIN Approval History

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What ERYTHROCIN Treats

5 indications

ERYTHROCIN is approved for 5 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lower Respiratory Tract Infection
  • Mycoplasma Pneumoniae Infection
  • Skin and Skin Structure Infection
  • Diphtheria
  • Erythrasma
Source: FDA Label

Drugs Similar to ERYTHROCIN

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ERYTHROMYCIN LACTOBIONATE
ERYTHROMYCIN LACTOBIONATE
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Lower Respiratory Tract Infection
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Shared indications:
Lower Respiratory Tract Infection
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Lower Respiratory Tract Infection
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Lower Respiratory Tract Infection
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Shared indications:
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1 shared
ANDA REPOSITORY
Shared indications:
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Hikma
Shared indications:
Lower Respiratory Tract Infection
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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.

ERYTHROCIN FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influen...

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Data Sources

FDA Approval: NDA050609 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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