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Details for New Drug Application (NDA): 203521

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NDA 203521 describes TRANEXAMIC ACID, which is a drug marketed by Acic Pharms, Akorn, Am Regent, Amneal Pharms Co, Apollo, Apotex, Aurobindo Pharma Ltd, Caplin, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Micro Labs, Mylan Institutional, Virtus Pharms, Xgen Pharms, Zydus Pharms, Exela Pharma Scs Llc, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, and Mylan, and is included in twenty-three NDAs. It is available from twenty-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. Twenty-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for 203521

Tradename:	TRANEXAMIC ACID
Applicant:	Emcure Pharms Ltd
Ingredient:	tranexamic acid
Patents:	0
Formulation / Manufacturing:	see details

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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-166	23155-166-41	10 VIAL, GLASS in 1 CARTON (23155-166-41) > 10 mL in 1 VIAL, GLASS (23155-166-31)
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	203521	ANDA	Heritage Pharmaceuticals Inc.	23155-524	23155-524-41	10 VIAL, GLASS in 1 CARTON (23155-524-41) > 10 mL in 1 VIAL, GLASS (23155-524-31)

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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