Product Details for: Viokace
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Tablet
Oral
10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS
351(a)
Viokace
Rx
002
Tablet
Oral
20,880USP UNITS; 78,300USP UNITS; 78,300USP UNITS
351(a)
Viokace
Rx
Proper Name
pancrelipase
pancrelipase
BLA Number
022542
022542
Applicant
Viokace, LLC
Viokace, LLC
Original Approval Date
March 1, 2012
March 1, 2012
Date of First Licensure