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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213081


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NDA 213081 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 213081
Tradename:EPTIFIBATIDE
Applicant:Shuangcheng
Ingredient:eptifibatide
Patents:0
Pharmacology for NDA: 213081
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 213081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 213081 ANDA Hainan Shuangcheng Pharmaceuticals Co., Ltd. 52958-040 52958-040-01 1 VIAL, SINGLE-DOSE in 1 CARTON (52958-040-01) / 100 mL in 1 VIAL, SINGLE-DOSE
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 213081 ANDA Hainan Shuangcheng Pharmaceuticals Co., Ltd. 52958-402 52958-402-01 1 VIAL, SINGLE-DOSE in 1 CARTON (52958-402-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Sep 7, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Apr 20, 2022TE:APRLD:No

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Preferred Citation:

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