<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70771-1594-4
</NDCCode>
<PackageDescription>
10 BLISTER PACK in 1 CARTON (70771-1594-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1594-2)
</PackageDescription>
<NDC11Code>
70771-1594-04
</NDC11Code>
<ProductNDC>
70771-1594
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Emtricitabine And Tenofovir Disoproxil Fumarate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Emtricitabine And Tenofovir Disoproxil Fumarate
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20210324
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212689
</ApplicationNumber>
<LabelerName>
Cadila Healthcare Limited
</LabelerName>
<SubstanceName>
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
</SubstanceName>
<StrengthNumber>
200; 300
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-11-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20221231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210324
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>