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Last Updated: December 6, 2019

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Details for New Drug Application (NDA): 020718

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NDA 020718 describes INTEGRILIN, which is a drug marketed by Schering and is included in one NDA. It is available from one supplier. Additional details are available on the INTEGRILIN profile page.

The generic ingredient in INTEGRILIN 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 020718
Tradename:INTEGRILIN
Applicant:Schering
Ingredient:eptifibatide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020718
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 020718
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718 NDA Merck Sharp & Dohme Corp. 0085-1136 0085-1136-02 1 VIAL, SINGLE-USE in 1 CARTON (0085-1136-02) > 100 mL in 1 VIAL, SINGLE-USE
INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718 NDA Merck Sharp & Dohme Corp. 0085-1136 0085-1136-01 1 VIAL, SINGLE-USE in 1 CARTON (0085-1136-01) > 100 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 020718
Tradename Dosage Ingredient NDA Submissiondate
INTEGRILIN INJECTABLE;INJECTION eptifibatide 020718 2008-12-18
INTEGRILIN INJECTABLE;INJECTION eptifibatide 020718 2008-09-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:May 18, 1998TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:May 18, 1998TE:APRLD:Yes

Expired US Patents for NDA 020718

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-001 May 18, 1998   Start Trial   Start Trial
Schering INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-001 May 18, 1998   Start Trial   Start Trial
Schering INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-002 May 18, 1998   Start Trial   Start Trial
Schering INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-002 May 18, 1998   Start Trial   Start Trial
Schering INTEGRILIN eptifibatide INJECTABLE;INJECTION 020718-001 May 18, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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