FDA.reportPublic FDA data

Application 021395

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRIVATIOTROPIUM BROMIDEPOWDER;INHALATIONEQ 0.018MG BASE/INHYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021395-001SPIRIVATIOTROPIUM BROMIDEEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021395-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021395-00180220822026-01-19U-1186Drug product2011-10-24
N021395-0018022082*PED2026-07-19Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021395-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021395-00180220822026-01-19U-1186Drug product2011-10-24a50c72e98297…
2026-08-01 22:54:322026-06N021395-0018022082*PED2026-07-19Pediatric extensiona50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spiriva HandiHalerTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.820839ef-e53d-47e8-a3b9-d911ff92e6a92025-11-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 021395
application number: NDA021395
ndc (product): 0597-0075
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsc6343458-617b-41ed-8e96-763e91dc8e902025-09-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021395
application number: NDA021395
Spiriva HandiHalerTIOTROPIUM BROMIDEA-S Medication Solutionsba462261-734a-4e9f-a5c0-5c676bc56a2e2023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021395
application number: NDA021395
ndc (product): 50090-4248

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0075SpirivaTIOTROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
50090-4248SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent
50090-4414SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent
50090-4414SpirivaTIOTROPIUM BROMIDEA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80802SUPPL 2025-01-02
80801SUPPL 2025-01-02
52280SUPPL2018-02-02
52255SUPPL2018-02-01
5248SUPPL2016-06-24
15360SUPPL2015-12-15
5247SUPPL2015-12-14
42136SUPPL2013-06-03
5246SUPPL2011-08-01
15359SUPPL2011-07-29
27662SUPPL2009-12-24
15358SUPPL2009-12-18
15356SUPPL2009-03-19
5245SUPPL2009-03-19
36814SUPPL2008-11-18
27661SUPPL2008-11-18
27660SUPPL2008-06-25
27659SUPPL2006-12-28
5244SUPPL2006-12-28
15357SUPPL2006-12-14
15355SUPPL2006-12-14
27658SUPPL2006-09-25
36813SUPPL2006-09-21
36812SUPPL2004-08-25
27657SUPPL2004-08-25
23653ORIG2004-07-13
21633ORIG2004-05-06
5243ORIG2004-03-16
15354ORIG2004-03-03