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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 206594

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NDA 206594 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, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Gland Pharma Ltd, Nexus, Actavis Labs Fl Inc, Ani Pharms, Aurobindo Pharma Usa, and Rubicon, and is included in twenty-eight NDAs. It is available from thirty-three 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 206594

Tradename:	TRANEXAMIC ACID
Applicant:	Epic Pharma Llc
Ingredient:	tranexamic acid
Patents:	0

Medical Subject Heading (MeSH) Categories for 206594

Antifibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Sep 28, 2017	TE:		RLD:	No

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