Data updated: Mar 10, 2026
EPINEPHRINE
EPINEPHRINE
Approved 1984-05-23
15
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-05-23
- Routes
- INHALATION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS, SOLUTION,CONCENTRATE
- Dosage Forms
- AEROSOL, METERED, SOLUTION, INJECTION
EPINEPHRINE Approval History
Loading approval history...
What EPINEPHRINE Treats
15 FDA approvalsOriginally approved for its first indication in 1984 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (May 1984)
- • Approved indication (Jul 2014)Label Letter
- • Approved indication (Oct 2015)Label Letter
- • Approved indication (Feb 2016)Label Letter
- • Approved indication (Jul 2018)Letter
- • Approved indication (Nov 2019)Label Letter
- • Approved indication (Apr 2020)Letter
- • Approved indication (Aug 2022)Label Letter
- • Approved indication (Sep 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Feb 2025)Letter
- • Approved indication (Mar 2025) NewLabel Letter
- • Approved indication (Jun 2025) New
- • Approved indication (Oct 2025) New
- • Approved indication (Dec 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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 FDA Label Details
ProEPINEPHRINE Patents & Exclusivity
Latest Patent: Jan 2045
Patents (1 active)
US12539283
Expires Jan 17, 2045
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.