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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091657

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NDA 091657 describes TRANEXAMIC ACID, which is a drug marketed by Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Micro Labs, Milla Pharms, Mylan Institutional, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Actavis Labs Fl Inc, Ani Pharms, Appco, Aurobindo Pharma Usa, Bionpharma, and Rubicon Research, and is included in thirty-one NDAs. It is available from thirty-six suppliers. Additional details are available on the TRANEXAMIC ACID profile page.

The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for 091657

Tradename:	TRANEXAMIC ACID
Applicant:	Mylan Institutional
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 091657

Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 091657

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 091657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	091657	ANDA	Mylan Institutional LLC	67457-197	67457-197-10	10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Nov 3, 2011	TE:	AP	RLD:	No

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