PROCARDIA XL
Details
- Status
- Prescription
- First Approved
- 1989-09-06
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
PROCARDIA XL Approval History
What PROCARDIA XL Treats
2 indicationsPROCARDIA XL is approved for 2 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasospastic Angina
- Chronic Stable Angina
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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.
PROCARDIA XL FDA Label Details
ProIndications & Usage
FDA Label (PDF)I. Vasospastic Angina PROCARDIA XL is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. PROCARDIA XL may also be used where the clinical presentation sug...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.