Glycopyrrolate / indacaterol Inhalant Powder

Brand(s)
Utibron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-10-29)
Oldest Current Product
2015-10-29
License(s)
NDA
RxNORM
INHALANT POWDER\GLYCOPYRROLATE:INDACATEROL
FDAOB
INHALATION\POWDER\GLYCOPYRROLATE: INDACATEROL MALEATE\rdfq
SPL Active
ORAL\CAPSULE\GLYCOPYRROLATE: INDACATEROL MALEATE
SPL Moiety
ORAL\CAPSULE\GLYCOPYRRONIUM: INDACATEROL

product(s) by strength(s)

glycopyrrolate 0.0156 mg / indacaterol 0.0275 mg inhalant powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780664UtibronNDANovartis Pharmaceuticals Corporation2015-10-29GLYCOPYRROLATE, INDACATEROL MALEATEORALCAPSULENDA2079307782a48e-38bb-404a-94ef-051278d8bfef

application(s)

#idtitleapplicantapprovedapproved drug
1NDA207930UTIBRONNOVARTIS PHARMACEUTICALS CORP2015-10-29NDA207930_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA207930_001RXGLYCOPYRROLATE (15.6MCG/INH), INDACATEROL MALEATE (27.5MCG/INH)POWDERTrue2015-10-29UTIBRON

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
17782a48e-38bb-404a-94ef-051278d8bfef (view SPL)These highlights do not include all the information needed to use UTIBRON NEOHALER safely and effectively. See full prescribing information for UTIBRON NEOHALER. UTIBRONTM NEOHALER (indacaterol and glycopyrrolate) inhalation powder, for oral inhalation use Initial U.S. Approval: 2015prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-10-291000780664

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