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Data updated: Mar 10, 2026

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

BACITRACIN ZINC Corticosteroid Hormone Receptor Agonists
Immunology Approved 1995-10-30
2
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-10-30
Routes
OPHTHALMIC
Dosage Forms
OINTMENT

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Approval History

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What NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Treats

5 indications

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE is approved for 5 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammatory Ocular Conditions
  • Bacterial Infection
  • Infective Conjunctivitis
  • Chronic Anterior Uveitis
  • Corneal Injury
Source: FDA Label
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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.

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE FDA Label Details

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Indications & Usage

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic ante...

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Data Sources

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