Details for New Drug Application (NDA): 203521

NDA 203521 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 203521

Tradename:	TRANEXAMIC ACID
Applicant:	Avet Lifesciences
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 203521

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 203521

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 203521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	203521	ANDA	Emcure Pharmaceuticals Limited	14593-318	14593-318-01	10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	203521	ANDA	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	23155-166	23155-166-41	10 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Aug 12, 2014	TE:	AP	RLD:	No

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