Data updated: Mar 10, 2026
CHLORAPREP ONE-STEP
CHLORHEXIDINE GLUCONATE
Approved 2000-07-14
1
Indication
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2000-07-14
- Routes
- TOPICAL
- Dosage Forms
- SPONGE
Companies
Website: ↗
CHLORAPREP ONE-STEP Approval History
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What CHLORAPREP ONE-STEP Treats
1 FDA approvalsOriginally approved for its first indication in 2000 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2000)Letter
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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.
CHLORAPREP ONE-STEP FDA Label Details
ProCHLORAPREP ONE-STEP Patents & Exclusivity
Latest Patent: Apr 2027
Patents (12 active)
US7422388
Expires Apr 25, 2027
+ 2 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.