Product Details for: Zenpep

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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
5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS
351(a)
Zenpep
Rx
002
Capsule, Delayed Release
Oral
10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS
351(a)
Zenpep
Rx
003
Capsule, Delayed Release
Oral
15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS
351(a)
Zenpep
Rx
004
Capsule, Delayed Release
Oral
20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS
351(a)
Zenpep
Rx
005
Capsule, Delayed Release
Oral
3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS
351(a)
Zenpep
Rx
006
Capsule, Delayed Release
Oral
25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS
351(a)
Zenpep
Rx
007
Capsule, Delayed Release
Oral
40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS
351(a)
Zenpep
Rx
008
Capsule, Delayed Release
Oral
60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS
351(a)
Zenpep
Rx
Proper Name
pancrelipase
BLA Number
022210
Applicant
Aimmune Therapeutics, Inc.
Original Approval Date
August 27, 2009
Date of First Licensure
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