Details for New Drug Application (NDA): 203256

NDA 203256 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 203256

Tradename:	TRANEXAMIC ACID
Applicant:	Ani Pharms
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 203256

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 203256

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 203256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	TABLET;ORAL	203256	ANDA	American Health Packaging	60687-750	60687-750-21	30 BLISTER PACK in 1 CARTON (60687-750-21) / 1 TABLET in 1 BLISTER PACK (60687-750-11)
TRANEXAMIC ACID	tranexamic acid	TABLET;ORAL	203256	ANDA	ANI Pharmaceuticals, Inc.	62559-265	62559-265-30	30 TABLET in 1 BOTTLE (62559-265-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	650MG
Approval Date:	Jul 25, 2016	TE:	AB	RLD:	No

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