Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020725

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CREON (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))
60,000USP UNITS;12,000USP UNITS;38,000USP UNITS Marketing Status: Prescription

Active Ingredient: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Proprietary Name: CREON
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020725
Product Number: 002
Approval Date: Apr 30, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CREON (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))
15,000USP UNITS;3,000USP UNITS;9,500USP UNITS Marketing Status: Prescription

Active Ingredient: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Proprietary Name: CREON
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020725
Product Number: 004
Approval Date: Jul 12, 2011
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CREON (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))
30,000USP UNITS;6,000USP UNITS;19,000USP UNITS Marketing Status: Prescription

Active Ingredient: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Proprietary Name: CREON
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020725
Product Number: 001
Approval Date: Apr 30, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CREON (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))
180,000USP UNITS;36,000USP UNITS;114,000USP UNITS Marketing Status: Prescription

Active Ingredient: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Proprietary Name: CREON
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020725
Product Number: 005
Approval Date: Mar 14, 2013
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CREON (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE))
120,000USP UNITS;24,000USP UNITS;76,000USP UNITS Marketing Status: Prescription

Active Ingredient: PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Proprietary Name: CREON
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020725
Product Number: 003
Approval Date: Apr 30, 2009
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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