ERYTHROMYCIN LACTOBIONATE
Details
- Status
- Prescription
- First Approved
- 1989-05-09
- Routes
- INJECTION, Injection
- Dosage Forms
- INJECTABLE, Injectable
ERYTHROMYCIN LACTOBIONATE Approval History
What ERYTHROMYCIN LACTOBIONATE Treats
6 indicationsERYTHROMYCIN LACTOBIONATE is approved for 6 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Upper Respiratory Tract Infection
- Lower Respiratory Tract Infection
- Mycoplasma Pneumoniae Infection
- Skin and Skin Structure Infection
- Diphtheria
- Erythrasma
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ERYTHROMYCIN LACTOBIONATE FDA Label Details
ProIndications & Usage
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.