<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51525-7815-6
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 BOX (51525-7815-6) > 6 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
51525-7815-06
</NDC11Code>
<ProductNDC>
51525-7815
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Azelastine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Azelastine Hydrochloride
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
INTRAOCULAR
</RouteName>
<StartMarketingDate>
20101001
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA021127
</ApplicationNumber>
<LabelerName>
Wallace Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
AZELASTINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
.5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-01-30
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20171231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>