<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55545-1007-2
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 CARTON (55545-1007-2) > 10 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
55545-1007-02
</NDC11Code>
<ProductNDC>
55545-1007
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dorzolamide And Timolol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dorzolamide Hydrochloride And Timolol Maleate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20191116
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA205295
</ApplicationNumber>
<LabelerName>
FDC Limited
</LabelerName>
<SubstanceName>
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
</SubstanceName>
<StrengthNumber>
20; 5
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2020-01-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20191116
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>