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Generated: May 24, 2017

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Details for New Drug Application (NDA): 202286

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NDA 202286 describes TRANEXAMIC ACID, which is a drug marketed by Emcure Pharms Ltd, Mylan, Akorn, Aurobindo Pharma Ltd, Acic Fine Chems, Gland Pharma Ltd, Amneal Pharms Co, North Creek 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 sixteen NDAs. It is available from seventeen 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-one suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for NDA: 202286

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

Pharmacology for NDA: 202286

Physiological EffectDecreased Fibrinolysis

Suppliers and Packaging for NDA: 202286

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANEXAMIC ACID
tranexamic acid
TABLET;ORAL 202286 ANDA Golden State Medical Supply, Inc. 60429-084 60429-084-30 30 TABLET in 1 BOTTLE (60429-084-30)
TRANEXAMIC ACID
tranexamic acid
TABLET;ORAL 202286 ANDA Apotex Corp. 60505-3638 60505-3638-1 100 TABLET in 1 BOTTLE (60505-3638-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength650MG
Approval Date:Jan 27, 2014TE:ABRLD:No


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