Data updated: May 26, 2026
NEOMYCIN AND POLYMYXIN B SULFATE (neomycin sulfate)
Infectious Disease
Approved 1986-04-08
2
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Prescription
- First Approved
- 1986-04-08
- Routes
- IRRIGATION
- Dosage Forms
- SOLUTION
Companies
Website: ↗
NEOMYCIN AND POLYMYXIN B SULFATE Approval History
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Original
New Indication
New Form
Label Update
11 FDA actions from 1986 to 2015
Jul 2015 SUPPL
Mfg · Manufacturing (CMC)
May 2006 SUPPL
Label · Labeling
Jan 2006 ORIGINAL
Update
Feb 1999 SUPPL
Mfg
Feb 1999 SUPPL
Mfg
Dec 1996 SUPPL
Mfg
Aug 1995 SUPPL
Mfg
Jan 1992 SUPPL
Mfg
May 1989 SUPPL
Mfg
Apr 1986 ORIGINAL
Update
What NEOMYCIN AND POLYMYXIN B SULFATE Treats
2 FDA approvalsOriginally approved for its first indication in 1986 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Apr 1986)
- • Approved indication (Jan 2006)
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07180615 NeoRiDe | 2025-01074 | Ph 4 | not yet recruiting | Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery |
| NCT03557008 results posted | IRB00101567 | Ph 4 | completed | Responses to Rabies Vaccine in Adults With or Without Antibiotics |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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 SULFATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.