salmeterol Dry Powder Inhaler

Brand(s)
Serevent
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-02-10)
Oldest Current Product
1997-11-25
License(s)
NDA
RxNORM
DRY POWDER INHALER\SALMETEROL
FDAOB
INHALATION\POWDER\SALMETEROL XINAFOATE\rdfq
SPL Active
ORAL\POWDER, METERED\SALMETEROL XINAFOATE
SPL Moiety
ORAL\POWDER, METERED\SALMETEROL

product(s) by strength(s)

60 actuat salmeterol 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730521SereventNDAGlaxosmithkline Llc1997-11-25SALMETEROL XINAFOATEORALPOWDER, METEREDNDA02069212d9728e-6b5c-4aee-bfb0-745e542ed2e4

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1682588961SereventNDADispensing Solutions, Inc.1997-11-25SALMETEROL XINAFOATEORALPOWDER, METERED001730521NDA020692c4925b2c-bde1-45fd-8109-dc75bee3b7a3

28 actuat salmeterol 0.05 mg/actuat dry powder inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730520SereventNDAGlaxosmithkline Llc1997-12-01SALMETEROL XINAFOATEORALPOWDER, METEREDNDA02069212d9728e-6b5c-4aee-bfb0-745e542ed2e4

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020692SEREVENTGLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND1997-09-19p5873360, SUBSTANCENDA020692_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020692_001RXSALMETEROL XINAFOATE (EQ 0.05MG BASE/INH)POWDERTrue1997-09-19SEREVENT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5873360 (view patent)2016-02-23NDA020692, NDA020833, NDA021077, NDA203975, NDA204275, NDA205382, NDA205625fluticasone / salmeterol Dry Powder Inhaler
fluticasone / vilanterol Dry Powder Inhaler
umeclidinium Dry Powder Inhaler
fluticasone Dry Powder Inhaler
umeclidinium / vilanterol Dry Powder Inhaler

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112d9728e-6b5c-4aee-bfb0-745e542ed2e4 (view SPL)These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS.SEREVENT DISKUS(salmeterol xinafoate inhalation powder)FOR ORAL INHALATION USEInitial U.S. Approval: 1994prescriptionHuman PrescriptionGlaxosmithkline Llc2015-02-1017001730520, 001730521
2c4925b2c-bde1-45fd-8109-dc75bee3b7a3 (view SPL)These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS.SEREVENT DISKUS(salmeterol xinafoate inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 1994prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-09-272682588961

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