tiotropium Inhalant Powder

Brand(s)
Spiriva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-04-07)
Oldest Current Product
2004-07-14
License(s)
NDA
RxNORM
INHALANT POWDER\TIOTROPIUM
FDAOB
INHALATION\POWDER\TIOTROPIUM BROMIDE\rdfq
SPL Active
ORAL\CAPSULE\TIOTROPIUM BROMIDE MONOHYDRATE
SPL Moiety
ORAL\CAPSULE\TIOTROPIUM

product(s) by strength(s)

tiotropium 0.018 mg/actuat inhalant powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970075SpirivaNDABoehringer Ingelheim Pharmaceuticals, Inc.2005-10-11TIOTROPIUM BROMIDE MONOHYDRATEORALCAPSULENDA021395820839ef-e53d-47e8-a3b9-d911ff92e6a9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560215SpirivaNDALake Erie Medical Dba Quality Care Products Llc2005-10-11TIOTROPIUM BROMIDE MONOHYDRATEORALCAPSULE005970075NDA021395910fae46-5eaf-427f-b137-e4e775b065c7
2548685109SpirivaNDAPhysicians Total Care, Inc.2004-07-14TIOTROPIUM BROMIDE MONOHYDRATEORALCAPSULE005970075NDA0213951cf82d42-5ad0-4b86-838e-9230c61cf3d4

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021395SPIRIVABOEHRINGER INGELHEIM PHARMACEUTICALS INC2004-01-30p8022082, ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE, SUBSTANCE
p7070800, FOR THE LONG-TERM, SUBSTANCE
p7694676, SUBSTANCE
p7642268, SUBSTANCE
pRE38912, SUBSTANCE
p7309707, SUBSTANCE
pRE39820, FOR THE LONG-TERM, SUBSTANCE
p6777423, SUBSTANCE
p6908928, TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE/ FOR THE LONG-TERM, SUBSTANCE
NDA021395_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021395_001RXTIOTROPIUM BROMIDE (EQ 0.018MG BASE/INH)POWDERTrue2004-01-30SPIRIVA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6777423 (view patent)2021-09-24NDA021395
2p6908928 (view patent)2021-09-24NDA021395
3p7070800 (view patent)2022-01-22NDA021395
4p7309707 (view patent)2021-09-24NDA021395
5p7642268 (view patent)2021-09-24NDA021395
6p7694676 (view patent)2027-03-12NDA021395
7p8022082 (view patent)2026-01-19NDA021395
8pRE38912 (view patent)2021-10-11NDA021395
9pRE39820 (view patent)2018-01-30NDA021395, NDA021936, NDA206756tiotropium Metered Dose Inhaler
olodaterol / tiotropium Metered Dose Inhaler

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11cf82d42-5ad0-4b86-838e-9230c61cf3d4 (view SPL)These highlights do not include all the information needed to use SPIRIVA HandiHaler safely and effectively. See full prescribing information for SPIRIVA HandiHaler. SPIRIVA HandiHaler (tiotropium bromide inhalation powder) Capsules for Respiratory Inhalation DO NOT Swallow SPIRIVA Capsules FOR ORAL INHALATION ONLY with the HandiHaler Device Initial U.S. Approval: 2004prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-03-183548685109
2820839ef-e53d-47e8-a3b9-d911ff92e6a9 (view SPL)These highlights do not include all the information needed to use SPIRIVA HandiHaler safely and effectively. See full prescribing information for SPIRIVA HandiHaler. SPIRIVA HandiHaler (tiotropium bromide inhalation powder)Capsules for Respiratory Inhalation DO NOT Swallow SPIRIVA CapsulesFOR ORAL INHALATION ONLY with the HandiHaler Device Initial U.S. Approval: 2004prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-04-0718005970075
3910fae46-5eaf-427f-b137-e4e775b065c7 (view SPL)These highlights do not include all the information needed to use SPIRIVA HandiHaler safely and effectively. See full prescribing information for SPIRIVA HandiHaler. SPIRIVA HandiHaler (tiotropium bromide inhalation powder)Capsules for Respiratory Inhalation DO NOT Swallow SPIRIVA CapsulesFOR ORAL INHALATION ONLY with the HandiHaler Device Initial U.S. Approval: 2004prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-05-313831353560215

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