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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Argus Health
US Department of Justice
Queensland Health
Fish and Richardson

Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206127

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NDA 206127 describes EPTIFIBATIDE, which is a drug marketed by Aurobindo Pharma Ltd, Teva Pharms Usa, Amneal Pharms, and Akorn, and is included in five 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 thirteen 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 NDA: 206127

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
INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-218 55150-218-99 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) > 100 mL in 1 VIAL, SINGLE-DOSE
INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-219 55150-219-10 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 8, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Dec 8, 2015TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
US Department of Justice
US Army
Queensland Health
Farmers Insurance

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