Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209864


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NDA 209864 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hainan Poly, Hybio, Meitheal, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 209864
Tradename:EPTIFIBATIDE
Applicant:Hainan Poly
Ingredient:eptifibatide
Patents:0
Pharmacology for NDA: 209864
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 209864
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 209864 ANDA Slate Run Pharmaceuticals, LLC 70436-026 70436-026-80 10 mL in 1 VIAL (70436-026-80)
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 209864 ANDA Slate Run Pharmaceuticals, LLC 70436-027 70436-027-80 100 mL in 1 VIAL (70436-027-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jan 25, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Jan 25, 2019TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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