<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
47335-703-52
</NDCCode>
<PackageDescription>
6 POUCH in 1 CARTON (47335-703-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
47335-0703-52
</NDC11Code>
<ProductNDC>
47335-703
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Albuterol Sulfate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Albuterol Sulfate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20210611
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA207857
</ApplicationNumber>
<LabelerName>
Sun Pharmaceutical Industries, Inc.
</LabelerName>
<SubstanceName>
ALBUTEROL SULFATE
</SubstanceName>
<StrengthNumber>
.83
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-12-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210611
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>