Details for New Drug Application (NDA): 206713

NDA 206713 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-five 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 206713

Tradename:	TRANEXAMIC ACID
Applicant:	Micro Labs
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 206713

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 206713

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 206713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206713	ANDA	Micro Labs Limited	42571-189	42571-189-57	10 CARTON in 1 CARTON (42571-189-57) / 1 AMPULE in 1 CARTON (42571-189-56) / 10 mL in 1 AMPULE
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206713	ANDA	Micro Labs Limited	42571-314	42571-314-89	10 CARTON in 1 CARTON (42571-314-89) / 1 VIAL, GLASS in 1 CARTON (42571-314-88) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Jun 27, 2017	TE:	AP	RLD:	No

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