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Covington
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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206127

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NDA 206127 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Akorn, Amneal Pharms, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in six NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 206127
Tradename:EPTIFIBATIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:eptifibatide
Patents:0
Formulation / Manufacturing:see details
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 AuroMedics Pharma LLC 55150-218 N 55150-218-99
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-219 N 55150-219-10

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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