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Data updated: May 26, 2026

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE (bacitracin zinc)

Corticosteroid Hormone Receptor Agonists
Infectious Disease Approved 1995-10-30

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE is indicated for the treatment of Inflammatory Ocular Conditions; Bacterial Infection; Infective Conjunctivitis; Chronic Anterior Uveitis; Corneal Injury.

Source: FDA Label • BAUSCH AND LOMB
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
30
Years on Market

Details

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

Companies

BAUSCH AND LOMB SCIEGEN PHARMS
Active Ingredient: BACITRACIN ZINC , HYDROCORTISONE , NEOMYCIN SULFATE , POLYMYXIN B SULFATE

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

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Original
New Indication
New Form
Label Update
21 FDA actions from 1995 to 2017
Mar 2017 SUPPL
Mfg · Manufacturing (CMC)
Jul 2012 ORIGINAL
Update
Aug 2002 SUPPL
Mfg · Manufacturing (CMC)

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

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Competitive Set

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Indication competitors

10

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

LOTEPREDNOL ETABONATE AND TOBRAMYCIN
ALEMBIC
2025 9 indic.
SIMLANDI
ALVOTECH USA
2024 9 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 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

3 of 9

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

MAXITROL
DEXAMETHASONE
4 shared
HARROW EYE
Shared indications:
Inflammatory Ocular ConditionsInfective ConjunctivitisChronic Anterior Uveitis +1 more
LOTEPREDNOL ETABONATE AND TOBRAMYCIN
LOTEPREDNOL ETABONATE
3 shared
ALEMBIC
Shared indications:
Inflammatory Ocular ConditionsChronic Anterior UveitisCorneal Injury
TOBRADEX
DEXAMETHASONE
3 shared
Novartis
Shared indications:
Inflammatory Ocular ConditionsChronic Anterior UveitisCorneal Injury
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Key Completed Trials

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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.

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

Indications & Usage

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE is indicated for the treatment of Inflammatory Ocular Conditions; Bacterial Infection; Infective Conjunctivitis; Chronic Anterior Uveitis; Corneal Injury.

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Data Sources

FDA Approval: ANDA064068 → Label: DailyMed → Trials: ClinicalTrials.gov →

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