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Data updated: Mar 10, 2026

REMIFENTANIL HYDROCHLORIDE

REMIFENTANIL HYDROCHLORIDE
Ophthalmology Approved 2018-01-16
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2018-01-16
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Fresenius Kabi Hikma NIVAGEN PHARMS INC
Active Ingredient: REMIFENTANIL HYDROCHLORIDE

REMIFENTANIL HYDROCHLORIDE Approval History

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What REMIFENTANIL HYDROCHLORIDE Treats

1 indications

REMIFENTANIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
Source: FDA Label

REMIFENTANIL HYDROCHLORIDE Boxed Warning

ADDICTION, ABUSE, AND MISUSE Addiction, Abuse, and Misuse Remifentanil hydrochloride for injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Remifentanil hydrochloride for injection [see Warnings and Precautions ( 5.1 )] . WARNING: ADDICTION, ABUSE, AND MISUSE See full prescribing information for complete boxed warning . Remifentanil hydrochloride for injection expose...

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

REMIFENTANIL HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. • As an analgesic component of monitored anesthesia care in adult patients. Remifentanil hydrochloride for injection is an opioid agonist indicated for ...

⚠️ BOXED WARNING

WARNING: ADDICTION, ABUSE, AND MISUSE Addiction, Abuse, and Misuse Remifentanil hydrochloride for injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Remifentanil hydroch...

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Data Sources

FDA Approval: ANDA206223 → Label: DailyMed → Trials: ClinicalTrials.gov →

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