Details for New Drug Application (NDA): 217155

NDA 217155 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 217155

Tradename:	TRANEXAMIC ACID
Applicant:	Amneal
Ingredient:	tranexamic acid
Patents:	0

Pharmacology for NDA: 217155

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 217155

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 217155

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	SOLUTION;INTRAVENOUS	217155	ANDA	Amneal Pharmaceuticals Private Limited	80830-2329	80830-2329-2	10 POUCH in 1 CARTON (80830-2329-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
TRANEXAMIC ACID	tranexamic acid	SOLUTION;INTRAVENOUS	217155	ANDA	Amneal Pharmaceuticals Private Limited	80830-2329	80830-2329-3	12 POUCH in 1 CARTON (80830-2329-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/100ML (10MG/ML)
Approval Date:	Oct 16, 2023	TE:	AP	RLD:	No

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