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Data updated: Mar 10, 2026

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NOREPINEPHRINE BITARTRATE
Cardiovascular Approved 2022-09-15
2
Indications
--
Phase 3 Trials
3
Years on Market

Details

Status
Prescription
First Approved
2022-09-15
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Approval History

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What NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Treats

1 indications

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
Source: FDA Label

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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.

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states.

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Patents & Exclusivity

Latest Patent: Apr 2039

Patents (107 active)

US10888534 Expires Apr 26, 2039
US11413259 Expires Jan 30, 2038
US10420735 Expires Jan 30, 2038
US10226436 Expires Jan 30, 2038
US10568850 Expires Jan 30, 2038
US12245996 Expires Jan 30, 2038
US10159657 Expires Jan 30, 2038
US11602508 Expires Jan 30, 2038
USRE49443 Expires Feb 26, 2035
USRE49422 Expires Feb 26, 2035
+ 97 more patents
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.