Details for New Drug Application (NDA): 212676

NDA 212676 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 212676

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

Pharmacology for NDA: 212676

Physiological Effect

Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 212676

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 212676

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	212676	ANDA	Provepharm Inc.	81284-611	81284-611-10	10 VIAL, SINGLE-DOSE in 1 CARTON (81284-611-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-611-00)
TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	212676	ANDA	Provepharm Inc.	81284-612	81284-612-10	10 VIAL, SINGLE-DOSE in 1 CARTON (81284-612-10) / 10 mL in 1 VIAL, SINGLE-DOSE (81284-612-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Jul 17, 2019	TE:	AP	RLD:	No

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