<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58914-005-50
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (58914-005-50) > 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE
</PackageDescription>
<NDC11Code>
58914-0005-50
</NDC11Code>
<ProductNDC>
58914-005
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ultresa
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pancrelipase
</NonProprietaryName>
<DosageFormName>
CAPSULE, DELAYED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20120301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA022222
</ApplicationNumber>
<LabelerName>
Aptalis Pharma US, Inc
</LabelerName>
<SubstanceName>
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
</SubstanceName>
<StrengthNumber>
46000; 23000; 46000
</StrengthNumber>
<StrengthUnit>
[USP'U]/1; [USP'U]/1; [USP'U]/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-10-17
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>