Product Details for: Pertzye
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PRODUCT LABEL
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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
8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS
351(a)
Pertzye
Rx
002
Capsule, Delayed Release
Oral
16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS
351(a)
Pertzye
Rx
003
Capsule, Delayed Release
Oral
4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS
351(a)
Pertzye
Rx
004
Capsule, Delayed Release
Oral
24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS
351(a)
Pertzye
Rx
Proper Name
pancrelipase
pancrelipase
BLA Number
022175
022175
Applicant
Digestive Care, Inc.
Digestive Care, Inc.
Original Approval Date
May 17, 2012
May 17, 2012
Date of First Licensure