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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208554


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NDA 208554 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hybio, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, and USV, and is included in fourteen NDAs. It is available from ten 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. Ten suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 208554
Tradename:EPTIFIBATIDE
Applicant:Baxter Hlthcare Corp
Ingredient:eptifibatide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208554
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 208554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 208554 ANDA Baxter Healthcare Corporation 0338-9558 0338-9558-10 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Nov 23, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Nov 23, 2018TE:APRLD:No

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