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FDA Approval

Tranexamic Acid

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Almaject, Inc.
DUNS: 116626205
Effective Date
November 28, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tranexamic acid(100 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tranexamic Acid

Product Details

NDC Product Code
72611-760
Application Number
ANDA207239
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
June 25, 2021
Code: 6T84R30KC1Class: ACTIBQuantity: 100 mg in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
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