Product Details for: Retavase
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
10UNITS
Single-Dose Vial
351(a)
Retavase
Rx
Proper Name
reteplase
reteplase
BLA Number
103786
103786
Applicant
Chiesi USA, Inc.
Chiesi USA, Inc.
Original Approval Date
October 30, 1996
October 30, 1996
Date of First Licensure