TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

THIAMINE HYDROCHLORIDE

THIAMINE HYDROCHLORIDE
Approved 1972-06-20
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
53
Years on Market

Details

Status
Discontinued
First Approved
1972-06-20
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

LUITPOLD BEL MAR EUGIA PHARMA Pfizer SAGENT PHARMS INC CAPLIN Fresenius Kabi PARKE DAVIS EPIC PHARMA LLC Viatris DELL LABS GLAND ABRAXIS PHARM WATSON LABS ASPIRO WEST-WARD PHARMS INT Dr. Reddy's ONESOURCE SPECIALTY
Active Ingredient: THIAMINE HYDROCHLORIDE

THIAMINE HYDROCHLORIDE Approval History

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What THIAMINE HYDROCHLORIDE Treats

15 FDA approvals

Originally approved for its first indication in 1972 . Covers 15 distinct patient populations.

  • Other (15)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

THIAMINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA080667 → Trials: ClinicalTrials.gov →

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