Product Details for: Creon

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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
6,000USP UNITS; 19,000USP UNITS; 30,000USP UNITS
351(a)
Creon
Rx
002
Capsule, Delayed Release
Oral
12,000USP UNITS; 38,000USP UNITS; 60,000USP UNITS
351(a)
Creon
Rx
003
Capsule, Delayed Release
Oral
24,000USP UNITS; 76,000USP UNITS; 120,000USP UNITS
351(a)
Creon
Rx
004
Capsule, Delayed Release
Oral
3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS
351(a)
Creon
Rx
005
Capsule, Delayed Release
Oral
36,000USP UNITS; 114,000USP UNITS; 180,000USP UNITS
351(a)
Creon
Rx
Proper Name
pancrelipase
BLA Number
020725
Applicant
AbbVie Inc.
Original Approval Date
April 30, 2009
Date of First Licensure
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