TheraRadar
Data updated: May 26, 2026

REZIPRES (ephedrine hydrochloride)

Cardiovascular Approved 2021-06-14
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2021-06-14
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Dr. Reddy's
Active Ingredient: EPHEDRINE HYDROCHLORIDE

REZIPRES Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2021
Jun 2021 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What REZIPRES Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

REZIPRES FDA Label Details

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Data Sources

FDA Approval: NDA213536 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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