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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201885

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NDA 201885 describes TRANEXAMIC ACID, which is a drug marketed by Acic Fine Chems, Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Mylan Institutional, Virtus Pharms, Viva Hlthcare, X-gen Pharms Inc, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Amerigen Pharms Ltd, Apotex Inc, and Mylan, and is included in nineteen NDAs. It is available from twenty suppliers. Additional details are available on the TRANEXAMIC ACID profile page.

The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 201885
Tradename:TRANEXAMIC ACID
Applicant:Luitpold
Ingredient:tranexamic acid
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 201885
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 201885
Suppliers and Packaging for NDA: 201885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 201885 ANDA American Regent, Inc. 0517-0960 N 0517-0960-01
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 201885 ANDA American Regent, Inc. 0517-0960 N 0517-0960-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Aug 10, 2011TE:APRLD:No

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