<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
39328-090-16
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 CARTON (39328-090-16) > 473 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
39328-0090-16
</NDC11Code>
<ProductNDC>
39328-090
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pregabalin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pregabalin
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20220614
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212604
</ApplicationNumber>
<LabelerName>
Patrin Pharma, Inc.
</LabelerName>
<SubstanceName>
PREGABALIN
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule>
CV
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2022-06-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220614
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>