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Serving leading biopharmaceutical companies globally:

US Department of Justice
Baxter
McKesson
Covington
Novartis
Accenture
Johnson and Johnson
Farmers Insurance
Federal Trade Commission
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Generated: November 17, 2017

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 Viva Hlthcare, Emcure Pharms Ltd, Zydus Pharms Usa Inc, Mylan, Akorn, Aurobindo Pharma Ltd, Acic Fine Chems, Gland Pharma Ltd, Amneal Pharms Co, Virtus Pharms, Amerigen Pharms Ltd, Mylan Institutional, X-gen Pharms Inc, Luitpold, Apotex Inc, Actavis Labs Fl Inc, and Fresenius Kabi Usa, 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:
1
Applicant:
1
Ingredient:
1
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 0517-0960-01 1 VIAL, GLASS in 1 CARTON (0517-0960-01) > 10 mL in 1 VIAL, GLASS
TRANEXAMIC ACID
tranexamic acid
INJECTABLE;INJECTION 201885 ANDA American Regent, Inc. 0517-0960 0517-0960-10 10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

UBS
Queensland Health
Johnson and Johnson
AstraZeneca
US Department of Justice
Mallinckrodt
Covington
Chinese Patent Office
Teva
Novartis

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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