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Medicines · US (FDA)

FDA 2024

Amino acids

Tranexamic Acid

Approved 16 Apr 2024IntravenousSolution

The FDA lists this product in 32 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: TRANEXAMIC ACID 1GM/100ML (10MG/ML)

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

TRANEXAMIC ACID 100MG/ML · InjectableANDA091657-001 · Prescription
TRANEXAMIC ACID 650MG · TabletANDA202093-001 · Prescription
TRANEXAMIC ACID 100MG/ML · InjectableANDA206634-001 · Discontinued
TRANEXAMIC ACID 100MG/ML · InjectableANDA207239-001 · Prescription
TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionThis page
TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionANDA218242-001 · Prescription
TRANEXAMIC ACID 100MG/ML · InjectableANDA202373-001 · Prescription
TRANEXAMIC ACID 100MG/ML · InjectableANDA206713-001 · Prescription
TRANEXAMIC ACID 100MG/ML · InjectableANDA209860-001 · Prescription
TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionANDA217155-001 · Prescription
TRANEXAMIC ACID 650MG · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA218729-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA205228-001 · Discontinued

TRANEXAMIC ACID 100MG/ML · InjectableANDA206594-001 · Discontinued

TRANEXAMIC ACID 100MG/ML · InjectableANDA212360-001 · Prescription

TRANEXAMIC ACID 650MG · TabletANDA218320-001 · Prescription

TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionANDA218896-001 · Prescription

TRANEXAMIC ACID 650MG · TabletANDA219123-001 · Discontinued

TRANEXAMIC ACID 100MG/ML · InjectableANDA201580-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA202436-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA203521-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA208840-001 · Prescription

TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionNDA212020-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA212676-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA091596-001 · Discontinued

TRANEXAMIC ACID 650MG · TabletANDA219702-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA202755-001 · Discontinued

TRANEXAMIC ACID 650MG · TabletANDA202286-001 · Discontinued

TRANEXAMIC ACID 100MG/ML · InjectableANDA205035-001 · Prescription

TRANEXAMIC ACID 650MG · TabletANDA205133-001 · Prescription

TRANEXAMIC ACID 100MG/ML · InjectableANDA201885-001 · Prescription

TRANEXAMIC ACID 650MG · TabletANDA203256-001 · Prescription

TRANEXAMIC ACID 1GM/100ML (10MG/ML) · SolutionANDA218599-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA216877.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Tranexamic Acid
Drug class: Amino acids
Route: Intravenous
Dosage form: Solution
Applicant: Nexus
Status: Prescription
FDA approval: 16 Apr 2024
Application: ANDA216877-001
RxCUI: 10691