Last Updated: June 25, 2026

Details for New Drug Application (NDA): 219123

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NDA 219123 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, I 3 Pharms, and Rubicon Research, and is included in thirty-two NDAs. It is available from thirty-four 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-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for 219123

Tradename:	TRANEXAMIC ACID
Applicant:	Bionpharma
Ingredient:	tranexamic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 219123

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	650MG
Approval Date:	Aug 19, 2025	TE:	AB	RLD:	No

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