Glycopyrrolate Inhalant Powder

Brand(s)
Seebri
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
FDAOB
INHALATION\POWDER\GLYCOPYRROLATE\rdfq
SPL Active
ORAL\CAPSULE\GLYCOPYRROLATE
SPL Moiety
ORAL\CAPSULE\GLYCOPYRRONIUM

product(s) by strength(s)

glycopyrrolate 0.0156 mg inhalant powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780662SeebriNDANovartis Pharmaceuticals Corporation2015-10-29GLYCOPYRROLATEORALCAPSULENDA2079238839674f-26d6-4302-9da0-258decfba9aa

application(s)

#idtitleapplicantapprovedapproved drug
1NDA207923SEEBRINOVARTIS PHARMACEUTICALS CORP2015-10-29NDA207923_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA207923_001RXGLYCOPYRROLATE (15.6MCG/INH)POWDERTrue2015-10-29SEEBRI

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
18839674f-26d6-4302-9da0-258decfba9aa (view SPL)These highlights do not include all the information needed to use SEEBRI NEOHALER safely and effectively. See full prescribing information for SEEBRI NEOHALER. SEEBRI NEOHALER (glycopyrrolate) inhalation powder, for oral inhalation useInitial U.S. Approval: 1961prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-10-291000780662

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