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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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US Department of Justice
Moodys
Fuji
Healthtrust
Covington
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091657

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NDA 091657 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 091657
Tradename:TRANEXAMIC ACID
Applicant:Mylan Institutional
Ingredient:tranexamic acid
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 091657
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 091657
Suppliers and Packaging for NDA: 091657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 091657 ANDA Mylan Institutional LLC 67457-197 67457-197-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Nov 3, 2011TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Harvard Business School
Deloitte
Chinese Patent Office
Daiichi Sankyo
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Dow

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