Details for New Drug Application (NDA): 201885

NDA 201885 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 201885

Tradename:	TRANEXAMIC ACID
Applicant:	Am Regent
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 201885

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 201885

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 201885

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	201885	ANDA	American Regent, Inc.	0517-0960	0517-0960-01	1 VIAL, GLASS in 1 CARTON (0517-0960-01) / 10 mL in 1 VIAL, GLASS
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	201885	ANDA	American Regent, Inc.	0517-0960	0517-0960-10	10 VIAL, GLASS in 1 CARTON (0517-0960-10) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Aug 10, 2011	TE:	AP	RLD:	No

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