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Data updated: Mar 10, 2026

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

NICARDIPINE HYDROCHLORIDE
Cardiovascular Approved 1992-01-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
34
Years on Market

Details

Status
Prescription
First Approved
1992-01-30
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

CHIESI
Active Ingredient: NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Approval History

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What CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Treats

2 indications

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Angina
  • Hypertension
Source: FDA Label

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Trial Timeline

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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 IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (Se...

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER 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

FDA Approval: NDA019734 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.