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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212020


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NDA 212020 describes TRANEXAMIC ACID, which is a drug marketed by Acic Pharms, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Actavis Labs Fl Inc, Ani Pharms, and Aurobindo Pharma Usa, and is included in twenty-four NDAs. It is available from thirty suppliers. Additional details are available on the TRANEXAMIC ACID profile page.

The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 212020
Tradename:TRANEXAMIC ACID
Applicant:Exela Pharma
Ingredient:tranexamic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212020
Physiological EffectDecreased Fibrinolysis
Medical Subject Heading (MeSH) Categories for 212020
Suppliers and Packaging for NDA: 212020
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 212020 NDA Exela Pharma Sciences, LLC 51754-0108 51754-0108-1 100 mL in 1 BAG (51754-0108-1)
TRANEXAMIC ACID tranexamic acid SOLUTION;INTRAVENOUS 212020 NDA Exela Pharma Sciences, LLC 51754-0108 51754-0108-3 1000 mL in 1 CASE (51754-0108-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/100ML (10MG/ML)
Approval Date:Apr 15, 2019TE:APRLD:Yes

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