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Last Updated: October 28, 2021

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Details for New Drug Application (NDA): 206634

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NDA 206634 describes TRANEXAMIC ACID, which is a drug marketed by Acic Pharms, Akorn, Am Regent, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Caplin, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Virtus Pharms, Xgen Pharms, Zydus Pharms, Exela Pharma, Actavis Labs Fl Inc, Ani Pharms, Apotex Inc, and Mylan Pharms Inc, and is included in twenty-three NDAs. It is available from twenty-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. Twenty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 206634
Ingredient:tranexamic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 206634
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 206634
Suppliers and Packaging for NDA: 206634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 206634 ANDA Akorn, Inc. 17478-017 17478-017-10 5 AMPULE in 1 CARTON (17478-017-10) > 10 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jun 9, 2016TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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