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Serving leading biopharmaceutical companies globally:

Colorcon
Accenture
Cantor Fitzgerald
Covington
Chinese Patent Office
Teva
Healthtrust
Cipla
AstraZeneca
Boehringer Ingelheim

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203521

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NDA 203521 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 203521
Tradename:TRANEXAMIC ACID
Applicant:Emcure Pharms Ltd
Ingredient:tranexamic acid
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 203521
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 203521
Suppliers and Packaging for NDA: 203521
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 203521 ANDA Heritage Pharmaceuticals Inc. 23155-166 23155-166-41 10 VIAL, GLASS in 1 CARTON (23155-166-41) > 10 mL in 1 VIAL, GLASS (23155-166-31)
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 203521 ANDA Heritage Pharmaceuticals Inc. 23155-524 23155-524-41 10 VIAL, GLASS in 1 CARTON (23155-524-41) > 10 mL in 1 VIAL, GLASS (23155-524-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Aug 12, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Argus Health
Baxter
Daiichi Sankyo
UBS
Citi
Fuji
Chubb

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