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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203258


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NDA 203258 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 203258
Tradename:EPTIFIBATIDE
Applicant:Mylan Labs Ltd
Ingredient:eptifibatide
Patents:0
Pharmacology for NDA: 203258
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 203258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 203258 ANDA Mylan Institutional LLC 67457-629 67457-629-10 1 VIAL in 1 CARTON (67457-629-10) / 10 mL in 1 VIAL
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 203258 ANDA Mylan Institutional LLC 67457-630 67457-630-10 1 VIAL in 1 CARTON (67457-630-10) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jul 20, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Jul 20, 2018TE:APRLD:No

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Preferred Citation:

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