Data updated: Mar 10, 2026
NOURESS
CYSTEINE HYDROCHLORIDE
Approved 2019-12-13
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-12-13
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
NOURESS Approval History
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What NOURESS Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
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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.
NOURESS FDA Label Details
ProNOURESS Patents & Exclusivity
Latest Patent: Mar 2039
Patents (19 active)
US10543186
Expires Mar 15, 2039
US11045438
Expires Mar 15, 2039
US10493051
Expires Mar 15, 2039
US10702490
Expires Mar 15, 2039
US11510941
Expires Mar 2, 2039
US10478453
Expires Jan 15, 2039
US10583155
Expires Jan 15, 2039
US11510942
Expires Jan 15, 2039
US11826383
Expires Jan 15, 2039
US10905714
Expires Jan 15, 2039
+ 9 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.