TheraRadar
Data updated: May 26, 2026

THAM (tromethamine)

Cardiovascular Approved 1965-12-16

THAM is indicated for the treatment of Metabolic Acidosis; Cardiac Arrest.

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
60
Years on Market

Details

Status
Prescription
First Approved
1965-12-16
Routes
INJECTION
Dosage Forms
SOLUTION

Companies

Pfizer
Active Ingredient: TROMETHAMINE

THAM Approval History

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Original
New Indication
New Form
Label Update
28 FDA actions from 1965 to 2013
Nov 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 2006 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What THAM Treats

2 indications

THAM is approved for 2 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metabolic Acidosis
  • Cardiac Arrest
Source: FDA Label

THAM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

SODIUM BICARBONATE
Pfizer
2005 11 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to THAM

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SODIUM BICARBONATE
SODIUM BICARBONATE
2 shared
Pfizer
Shared indications:
Metabolic AcidosisCardiac Arrest
TROMETHAMINE
TROMETHAMINE
2 shared
B BRAUN MEDICAL
Shared indications:
Metabolic AcidosisCardiac Arrest
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03078088 201608805 Ph 1 completed Airway Alkalinization and Nasal Colonization
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Active Pipeline

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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.

THAM FDA Label Details

Indications & Usage

FDA Label (PDF)

THAM is indicated for the treatment of Metabolic Acidosis; Cardiac Arrest.

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Data Sources

FDA Approval: NDA013025 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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