Data updated: Mar 10, 2026
CARDENE
NICARDIPINE HYDROCHLORIDE
Approved 1988-12-21
2
Indications
--
Phase 3 Trials
37
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-12-21
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
CARDENE Approval History
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What CARDENE Treats
2 FDA approvalsOriginally approved for its first indication in 1988 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 1988)
- • Approved indication (Jan 1992)
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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.
CARDENE FDA Label Details
ProCARDENE Patents & Exclusivity
Latest Patent: Dec 2027
Patents (22 active)
US9364564
Expires Dec 26, 2027
US7612102
Expires Dec 26, 2027
US8455524
Expires Apr 18, 2027
US7659291
Expires Apr 18, 2027
US11547758
Expires Apr 18, 2027
US10758616
Expires Apr 18, 2027
+ 12 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.