DEXMETHYLPHENIDATE HYDROCHLORIDE · PLATINUM
DEXMETHYLPHENIDATE HYDROCHLORIDE is FDA-approved to treat 1 condition (same as FOCALIN XR).
Details
- Status
- Prescription
- First Approved
- 2001-11-13
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET
DEXMETHYLPHENIDATE HYDROCHLORIDE Approval History
What DEXMETHYLPHENIDATE HYDROCHLORIDE Treats
1 indicationsDEXMETHYLPHENIDATE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as FOCALIN XR (same active ingredient).
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.
DEXMETHYLPHENIDATE HYDROCHLORIDE FDA Label Details
Indications & Usage
DEXMETHYLPHENIDATE HYDROCHLORIDE is FDA-approved to treat 1 condition — same approved indications as FOCALIN XR.
Looking for the branded version?
FOCALIN XR
Full clinical data, patents, trials, and competitive landscape for dexmethylphenidate hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.