CAFFEINE CITRATE
Details
- Status
- Prescription
- First Approved
- 2006-09-21
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- SOLUTION
Companies
CAFFEINE CITRATE Approval History
What CAFFEINE CITRATE Treats
10 FDA approvalsOriginally approved for its first indication in 2006 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Sep 2006)Letter
- • Approved indication (May 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Sep 2009)
- • Approved indication (Nov 2009)
- • Approved indication (Aug 2012)
- • Approved indication (Sep 2015)
- • Approved indication (Dec 2017)
- • Approved indication (Dec 2019)
CAFFEINE CITRATE Competitors
Pro1 other drug also targets Adenosine receptor A1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (Adenosine receptor A1). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CAFFEINE CITRATE FDA Label Details
ProIndications & Usage
Caffeine citrate injection is indicated for the treatment of apnea of prematurity.
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.