Data updated: Mar 10, 2026
CIPRO
CIPROFLOXACIN HYDROCHLORIDE
Approved 1987-10-22
17
Indications
--
Phase 3 Trials
3
Priority Reviews
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1987-10-22
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, FOR SUSPENSION, INJECTABLE
CIPRO Approval History
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What CIPRO Treats
17 FDA approvalsOriginally approved for its first indication in 1987 . Covers 17 distinct patient populations.
- Other (17)
Other
(17 approvals)- • Approved indication (Oct 1987) Priority
- • Approved indication (Dec 1990)
- • Approved indication (Jul 1994)
- • Approved indication (Sep 1995)
- • Approved indication (Sep 1996)
- • Approved indication (Oct 1996)
- • Approved indication (Oct 1996)
- • Approved indication (May 1997)
- • Approved indication (Jun 1997)
- • Approved indication (Aug 1997)
- • Approved indication (Sep 1997)
- • Approved indication (Apr 1998)
- • Approved indication (Sep 1998)
- • Approved indication (Aug 2000) Priority
- • Approved indication (Mar 2004) Priority
- • Approved indication (Jan 2005)
- • Approved indication (Feb 2015)
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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.
CIPRO FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.