TheraRadar
Data updated: May 26, 2026

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE (polymyxin b sulfate)

Ophthalmology Approved 1997-02-14

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is indicated for the treatment of Ocular Bacterial Infection; Acute Bacterial Conjunctivitis; Blepharoconjunctivitis.

Source: FDA Label • EPIC PHARMA LLC
4
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1997-02-14
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approval History

1998
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Original
New Indication
New Form
Label Update
31 FDA actions from 1997 to 2024
Aug 2024 ORIGINAL
Update
May 2020 SUPPL
Label · Labeling
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)

What TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Treats

3 indications

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ocular Bacterial Infection
  • Acute Bacterial Conjunctivitis
  • Blepharoconjunctivitis
Source: FDA Label

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Competitive Set

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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.

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Key Completed Trials

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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.

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE FDA Label Details

Indications & Usage

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is indicated for the treatment of Ocular Bacterial Infection; Acute Bacterial Conjunctivitis; Blepharoconjunctivitis.

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Data Sources

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