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PANCRELIPASE
FQ3DRG0N5K
US Approved Rx (2012)
First marketed in 1921
General
Record Details
Variant Concepts
3
Names
24
Classification
4
Identifiers
20
Mixture Components
3
Relationships
4
Active Moiety
3
PANCRELIPASE
FQ3DRG0N5K
US Approved Rx (2012)
First marketed in 1921
General
Approval Year
1921
1,468
Record Details
Substance Class
Mixture
Record UNII
FQ3DRG0N5K
Record Status
Validated (UNII)
Record Version
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Names
24
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Name
Type
Language
Name
Type
Language
CREON
Preferred Name
English
PANCRELIPASE
Official Name
English
Pancrelipase [WHO-DD]
Common Name
English
EUR-1008
Code
English
ULTRESA
Brand Name
English
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Classification
4
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Classification Tree
Code System
Code
Classification Tree
Code System
Code
Biological Agent
Pharmacologic Substance
[C1909]
Biological Agent
[C307]
Enzyme Replacement or Supplement Agent
NCI_THESAURUS
C29726
Subpart E--Requirements for Specific New Drugs or Devices
PART 310 -- NEW DRUGS
Subpart E--Requirements for Specific New Drugs or Devices
Sec. 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
CFR
21 CFR 310.543
Enzyme preparations
ATC
ALIMENTARY TRACT AND METABOLISM
DIGESTIVES, INCL. ENZYMES
DIGESTIVES, INCL. ENZYMES
Enzyme preparations
multienzymes (lipase, protease etc.)
WHO-ATC
A09AA02
Subpart B--Listing of Specific Substances Affirmed as GRAS
PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 184.1415 Animal lipase
CFR
21 CFR 184.1415
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Identifiers
20
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Code System
Code
Type
Description
Code System
Code
Type
Description
DRUG CENTRAL
5161
PRIMARY
NCI_THESAURUS
C29345
PRIMARY
ChEMBL
CHEMBL2108074
PRIMARY
DRUG BANK
DB00085
PRIMARY
MERCK INDEX
m8378
PRIMARY
Merck Index
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Mixture Components
3
All of the following components
must
be present:
8MYC33932O
PANCRELIPASE LIPASE
YOJ58O116E
PANCRELIPASE AMYLASE
3560D81V50
PANCRELIPASE PROTEASE
Relationships
4
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Type
Details
Related Record
Type
Details
PANCREAS PREPARATION
SUB_CONCEPT->SUBSTANCE
Amount:
Pancreatin
SUB_CONCEPT->SUBSTANCE
Amount:
8MYC33932O
PANCRELIPASE LIPASE
BASIS OF STRENGTH->SUBSTANCE
Amount:
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
SUB_CONCEPT->SUBSTANCE
Amount:
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Active Moiety
3
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Related Record
Type
Details
Related Record
Type
Details
3560D81V50
PANCRELIPASE PROTEASE
ACTIVE MOIETY
Amount:
YOJ58O116E
PANCRELIPASE AMYLASE
ACTIVE MOIETY
Amount:
8MYC33932O
PANCRELIPASE LIPASE
ACTIVE MOIETY
Amount:
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Definition References
(2)
