Data updated: Mar 10, 2026
EPHEDRINE SULFATE
EPHEDRINE SULFATE
Approved 2017-03-01
18
Indications
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-03-01
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
Companies
RENEW PHARMS SAGENT PHARMS INC Dr. Reddy's ZYDUS PHARMS Hikma XIROMED Fresenius Kabi EUGIA PHARMA MANKIND PHARMA GLAND AMNEAL CIVICA Novartis PH HEALTH CAPLIN
Active Ingredient: EPHEDRINE SULFATE
Website: ↗
EPHEDRINE SULFATE Approval History
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What EPHEDRINE SULFATE Treats
18 FDA approvalsOriginally approved for its first indication in 2017 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Mar 2017)Label Letter
- • Approved indication (Aug 2017)Letter
- • Approved indication (Oct 2019)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Oct 2020)Letter
- • Approved indication (Dec 2020)
- • Approved indication (Jun 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Apr 2022)
- • Approved indication (Apr 2022)
- • Approved indication (Mar 2023)
- • Approved indication (May 2023)
- • Approved indication (Jul 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Jan 2025)Letter
- • Approved indication (Mar 2025)
- • Approved indication (Dec 2025) New
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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.
EPHEDRINE SULFATE FDA Label Details
ProEPHEDRINE SULFATE Patents & Exclusivity
Latest Patent: Jan 2040
Patents (6 active)
US12029710
Expires Jan 22, 2040
US10869845
Expires Jan 22, 2040
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.