<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
10122-460-02
</NDCCode>
<PackageDescription>
1 CANISTER in 1 CARTON (10122-460-02) / 120 AEROSOL, METERED in 1 CANISTER
</PackageDescription>
<NDC11Code>
10122-0460-02
</NDC11Code>
<ProductNDC>
10122-460
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Trimbow
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate
</NonProprietaryName>
<DosageFormName>
AEROSOL, METERED
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20260514
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219622
</ApplicationNumber>
<LabelerName>
Chiesi USA, Inc.
</LabelerName>
<SubstanceName>
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
</SubstanceName>
<StrengthNumber>
86; 4.9; 10.6
</StrengthNumber>
<StrengthUnit>
ug/1; ug/1; ug/1
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-08-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260514
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>