Product Details for: Pancreaze

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Capsule, Delayed Release
Oral
4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS
351(a)
Pancreaze
Rx
002
Capsule, Delayed Release
Oral
10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS
351(a)
Pancreaze
Rx
003
Capsule, Delayed Release
Oral
16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS
351(a)
Pancreaze
Rx
004
Capsule, Delayed Release
Oral
21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS
351(a)
Pancreaze
Rx
005
Capsule, Delayed Release
Oral
2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS
351(a)
Pancreaze
Rx
006
Capsule, Delayed Release
Oral
37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS
351(a)
Pancreaze
Rx
Proper Name
pancrelipase
BLA Number
022523
Applicant
VIVUS LLC
Original Approval Date
April 12, 2010
Date of First Licensure
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