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Data updated: Mar 10, 2026

EPINEPHRINE (AUTOINJECTOR)

EPINEPHRINE Adrenergic alpha-Agonists
Cardiovascular Approved 2018-08-16
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-08-16
Routes
INTRAMUSCULAR, SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Teva
Active Ingredient: EPINEPHRINE

EPINEPHRINE (AUTOINJECTOR) Approval History

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What EPINEPHRINE (AUTOINJECTOR) Treats

2 indications

EPINEPHRINE (AUTOINJECTOR) is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
  • Septic Shock
Source: FDA Label

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LONG GROVE PHARMS
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NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
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PHENYLEPHRINE HYDROCHLORIDE
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Dr. Reddy's
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

EPINEPHRINE (AUTOINJECTOR) FDA Label Details

Pro

Indications & Usage

Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

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Data Sources

FDA Approval: ANDA090589 → Label: DailyMed → Trials: ClinicalTrials.gov →

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