Home Applications 021936 Application 021936
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPIRIVA RESPIMAT TIOTROPIUM BROMIDE SPRAY, METERED;INHALATION EQ 0.0025MG BASE/INH Yes Yes 002 SPIRIVA RESPIMAT TIOTROPIUM BROMIDE SPRAY, METERED;INHALATION EQ 0.00125MG BASE/INH Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021936-001 SPIRIVA RESPIMAT TIOTROPIUM BROMIDE EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-09-24 N021936-002 SPIRIVA RESPIMAT TIOTROPIUM BROMIDE EQ 0.00125MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2015-09-15
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021936-001 7396341 2026-10-10 Drug product, Delist requested 2014-10-20 N021936-001 9027967 2027-03-31 Drug product, Delist requested 2015-09-15 N021936-001 7396341*PED 2027-04-10 Pediatric extension N021936-001 9027967*PED 2027-09-30 Pediatric extension N021936-001 7837235 2028-03-13 Drug product, Delist requested 2014-10-20 N021936-001 7837235*PED 2028-09-13 Pediatric extension N021936-001 8733341 2030-10-16 Drug product, Delist requested 2015-09-15 N021936-001 8733341*PED 2031-04-16 Pediatric 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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021936-001 SPIRIVA RESPIMAT EQ 0.0025MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2014-09-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-002 SPIRIVA RESPIMAT EQ 0.00125MG BASE/INH SPRAY, METERED / INHALATION RLD, RS 2015-09-15 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N021936-001 7396341 2026-10-10 Drug product, Delist requested 2014-10-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 9027967 2027-03-31 Drug product, Delist requested 2015-09-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 7396341*PED 2027-04-10 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 9027967*PED 2027-09-30 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 7837235 2028-03-13 Drug product, Delist requested 2014-10-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 7837235*PED 2028-09-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 8733341 2030-10-16 Drug product, Delist requested 2015-09-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N021936-001 8733341*PED 2031-04-16 Pediatric extension a50c72e98297…
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0100 Spiriva Respimat tiotropium bromide inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0100 Spiriva Respimat tiotropium bromide inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0100 Spiriva Respimat tiotropium bromide inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0100 Spiriva Respimat tiotropium bromide inhalation spray Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current