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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. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the INTEGRILIN profile page.

The generic ingredient in INTEGRILIN is eptifibatide. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for NDA: 020718

Tradename:
INTEGRILIN
Applicant:
Schering
Ingredient:
eptifibatide
Patents:1
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 0085-1136-03 1 VIAL, SINGLE-USE in 1 CARTON (0085-1136-03) > 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:May 18, 1998TE:APRLD:Yes
Patent:5,807,825Patent Expiration:Sep 15, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:PLATELET AGGREGATION INHIBITORS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:May 18, 1998TE:APRLD:Yes
Patent:5,807,825Patent Expiration:Sep 15, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:PLATELET AGGREGATION INHIBITORS

Expired Orange Book Patents for NDA: 020718

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-001May 18, 19985,686,570► subscribe
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-001May 18, 19985,968,902► subscribe
Schering
INTEGRILIN
eptifibatide
INJECTABLE;INJECTION020718-002May 18, 19985,968,902► subscribe
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