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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205035

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NDA 205035 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 205035

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 205035

Physiological EffectDecreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for 205035

Suppliers and Packaging for NDA: 205035

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid INJECTABLE;INJECTION 205035 ANDA AuroMedics Pharma LLC 55150-188 55150-188-10 10 VIAL, SINGLE-USE in 1 CARTON (55150-188-10) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jan 14, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Chubb
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