<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43353-198-09
</NDCCode>
<PackageDescription>
9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-198-09)
</PackageDescription>
<NDC11Code>
43353-0198-09
</NDC11Code>
<ProductNDC>
43353-198
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ropinirole Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ropinirole Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20110920
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA078110
</ApplicationNumber>
<LabelerName>
Aphena Pharma Solutions - Tennessee, LLC
</LabelerName>
<SubstanceName>
ROPINIROLE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
2
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2020-01-01
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>