indacaterol Inhalant Powder

Brand(s)
Arcapta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2012-09-28)
Oldest Current Product
2011-07-01
License(s)
NDA
RxNORM
INHALANT POWDER\INDACATEROL
FDAOB
INHALATION\POWDER\INDACATEROL MALEATE\rdfq
SPL Active
ORAL\CAPSULE\INDACATEROL MALEATE
SPL Moiety
ORAL\CAPSULE\INDACATEROL

product(s) by strength(s)

indacaterol 0.075 mg/actuat inhalant powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780619ArcaptaNDANovartis Pharmaceuticals Corporation2011-07-01INDACATEROL MALEATEORALCAPSULENDA022383f7d013b1-5ee9-4126-8297-9efd9a5a8344

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022383ARCAPTA NEOHALERNOVARTIS PHARMACEUTICALS CORP2011-07-01p8658673, THE LONG TERM, SUBSTANCE
p6878721, THE LONG TERM, SUBSTANCE
p8479730, SUBSTANCE
p8067437, THE LONG TERM
NEW CHEMICAL ENTITY [2016-07-01]NDA022383_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022383_001RXINDACATEROL MALEATE (EQ 75MCG BASE)POWDERTrue2011-07-01ARCAPTA NEOHALER

patent(s)

#idexpiration dateapplication(s)
1p6878721 (view patent)2020-10-10NDA022383
2p8067437 (view patent)2020-06-02NDA022383
3p8479730 (view patent)2028-10-11NDA022383
4p8658673 (view patent)2020-06-02NDA022383

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f7d013b1-5ee9-4126-8297-9efd9a5a8344 (view SPL)These highlights do not include all the information needed to use ARCAPTA NEOHALER safely and effectively. See full prescribing information for ARCAPTA NEOHALER . ARCAPTA NEOHALER (indacaterol inhalation powder) Initial U.S. Approval: 2011prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2012-09-282000780619

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII