Data updated: Mar 10, 2026
SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDE
Approved 1982-07-28
22
Indications
--
Phase 3 Trials
43
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1982-07-28
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
EPIC PHARMA LLC MICRO LABS CHARTWELL RX Cipla CAPLIN AVET LIFESCIENCES ABRAXIS PHARM BE PHARMS AMNEAL Baxter SAGENT PHARMS INC PHARMOBEDIENT Dr. Reddy's XIROMED SLATE RUN PHARMA NEXUS AMPHASTAR PHARMS INC Viatris SOMERSET THERAPS LLC Teva Sun Pharma EUGIA PHARMA
Active Ingredient: SODIUM NITROPRUSSIDE
Website: ↗
SODIUM NITROPRUSSIDE Approval History
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What SODIUM NITROPRUSSIDE Treats
22 FDA approvalsOriginally approved for its first indication in 1982 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Jul 1982)
- • Approved indication (Mar 1992)
- • Approved indication (Dec 2016)Label Letter
- • Approved indication (May 2017)
- • Approved indication (May 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Apr 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Apr 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jul 2021)
- • Approved indication (Aug 2022)Letter
- • Approved indication (Nov 2022)
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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.
SODIUM NITROPRUSSIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.