Product Details for: Reopro
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2MG/ML
Single-Dose Vial
351(a)
Reopro
Disc
Proper Name
abciximab
abciximab
BLA Number
103575
103575
Applicant
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Original Approval Date
December 22, 1994
December 22, 1994
Date of First Licensure