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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206127


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NDA 206127 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hybio, Meitheal, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, and USV, and is included in fifteen NDAs. It is available from eight suppliers. Additional details are available on the EPTIFIBATIDE profile page.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 206127
Tradename:EPTIFIBATIDE
Applicant:Eugia Pharma
Ingredient:eptifibatide
Patents:0
Pharmacology for NDA: 206127
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 206127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127 ANDA Eugia US LLC 55150-218 55150-218-99 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) / 100 mL in 1 VIAL, SINGLE-DOSE
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127 ANDA Eugia US LLC 55150-219 55150-219-10 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 8, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Dec 8, 2015TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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