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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205133


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NDA 205133 describes TRANEXAMIC ACID, which is a drug marketed by Acic Pharms, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa, and is included in twenty-four NDAs. It is available from thirty 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-four suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 205133
Tradename:TRANEXAMIC ACID
Applicant:Aurobindo Pharma Usa
Ingredient:tranexamic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205133
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 205133
Suppliers and Packaging for NDA: 205133
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid TABLET;ORAL 205133 ANDA Aurobindo Pharma Limited 59651-839 59651-839-30 30 TABLET in 1 BOTTLE (59651-839-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength650MG
Approval Date:Sep 21, 2015TE:ABRLD:No

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