<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65145-154-01
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (65145-154-01) / 15 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
65145-0154-01
</NDC11Code>
<ProductNDC>
65145-154
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Timolol Maleate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Timolol Maleate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20240916
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218460
</ApplicationNumber>
<LabelerName>
Caplin Steriles Limited
</LabelerName>
<SubstanceName>
TIMOLOL MALEATE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-09-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240916
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>