<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55253-601-30
</NDCCode>
<PackageDescription>
30 TABLET, FILM COATED in 1 BOTTLE (55253-601-30)
</PackageDescription>
<NDC11Code>
55253-0601-30
</NDC11Code>
<ProductNDC>
55253-601
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Tiagabine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tiagabine Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20121221
</StartMarketingDate>
<EndMarketingDate>
20170831
</EndMarketingDate>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA020646
</ApplicationNumber>
<LabelerName>
CIMA LABS INC.
</LabelerName>
<SubstanceName>
TIAGABINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-09-01
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>