Application 021936

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRIVA RESPIMATTIOTROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.0025MG BASE/INHYesYes
002SPIRIVA RESPIMATTIOTROPIUM BROMIDESPRAY, METERED;INHALATIONEQ 0.00125MG BASE/INHYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021936-001SPIRIVA RESPIMATTIOTROPIUM BROMIDEEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24
N021936-002SPIRIVA RESPIMATTIOTROPIUM BROMIDEEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021936-00173963412026-10-10Drug product, Delist requested2014-10-20
N021936-00190279672027-03-31Drug product, Delist requested2015-09-15
N021936-0017396341*PED2027-04-10Pediatric extension
N021936-0019027967*PED2027-09-30Pediatric extension
N021936-00178372352028-03-13Drug product, Delist requested2014-10-20
N021936-0017837235*PED2028-09-13Pediatric extension
N021936-00187333412030-10-16Drug product, Delist requested2015-09-15
N021936-0018733341*PED2031-04-16Pediatric 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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-2484e616aacf4f…
2026-09-14 22:38:342026-08N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-1584e616aacf4f…
2026-08-18 06:07:402026-07N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2015-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021936-001SPIRIVA RESPIMATEQ 0.0025MG BASE/INHSPRAY, METERED / INHALATIONRLD, RS2014-09-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021936-002SPIRIVA RESPIMATEQ 0.00125MG BASE/INHSPRAY, METERED / INHALATIONRLD2015-09-1574a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,056 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N021936-00173963412026-10-10Drug product, Delist requested2014-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N021936-00190279672027-03-31Drug product, Delist requested2015-09-1584e616aacf4f…
2026-09-14 22:38:342026-08N021936-0017396341*PED2027-04-10Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N021936-0019027967*PED2027-09-30Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N021936-00178372352028-03-13Drug product, Delist requested2014-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N021936-0017837235*PED2028-09-13Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N021936-00187333412030-10-16Drug product, Delist requested2015-09-1584e616aacf4f…
2026-09-14 22:38:342026-08N021936-0018733341*PED2031-04-16Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N021936-00173963412026-10-10Drug product, Delist requested2014-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021936-00190279672027-03-31Drug product, Delist requested2015-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021936-0017396341*PED2027-04-10Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N021936-0019027967*PED2027-09-30Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N021936-00178372352028-03-13Drug product, Delist requested2014-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021936-0017837235*PED2028-09-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N021936-00187333412030-10-16Drug product, Delist requested2015-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021936-0018733341*PED2031-04-16Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021936-00173963412026-10-10Drug product, Delist requested2014-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-00190279672027-03-31Drug product, Delist requested2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-0017396341*PED2027-04-10Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-0019027967*PED2027-09-30Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-00178372352028-03-13Drug product, Delist requested2014-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-0017837235*PED2028-09-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-00187333412030-10-16Drug product, Delist requested2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021936-0018733341*PED2031-04-16Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00172844742024-08-26Drug product2014-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0017284474*PED2025-02-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00173963412026-10-10Drug product, Delist requested2014-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00190279672027-03-31Drug product, Delist requested2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0017396341*PED2027-04-10Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0019027967*PED2027-09-30Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00178372352028-03-13Drug product, Delist requested2014-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0017837235*PED2028-09-13Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00187333412030-10-16Drug product, Delist requested2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0018733341*PED2031-04-16Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-00272844742024-08-26Drug product2015-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021936-0027284474*PED2025-02-26Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021936-0017284474*PED2025-02-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021936-00173963412026-10-10Drug product, Delist requested2014-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021936-00190279672027-03-31Drug product, Delist requested2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021936-0017396341*PED2027-04-10Pediatric extension6a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021936-001NPP2020-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021936-001PED2020-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021936-002PED2019-03-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021936-002NPP2020-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021936-002PED2020-08-1574a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021936-001NPP2020-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021936-001PED2020-08-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021936-002NPP2020-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021936-002PED2020-08-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021936-001NPP2020-02-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021936-001PED2020-08-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021936-002NPP2020-02-15c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021936-002PED2020-08-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021936-001NPP2020-02-153f01610625f2…
2019-12-14 00:12 UTC2019-12N021936-001PED2020-08-153f01610625f2…
2019-12-14 00:12 UTC2019-12N021936-002PED2019-03-153f01610625f2…
2019-12-14 00:12 UTC2019-12N021936-002NPP2020-02-153f01610625f2…
2019-12-14 00:12 UTC2019-12N021936-002PED2020-08-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021936-001NPP2020-02-15b00525d2431f…
2019-09-15 20:21 UTC2019-09N021936-001PED2020-08-15b00525d2431f…
2019-09-15 20:21 UTC2019-09N021936-002PED2019-03-15b00525d2431f…
2019-09-15 20:21 UTC2019-09N021936-002NPP2020-02-15b00525d2431f…
2019-09-15 20:21 UTC2019-09N021936-002PED2020-08-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021936-001NPP2020-02-15ea99ee380514…
2019-07-19 19:46 UTC2019-07N021936-001PED2020-08-15ea99ee380514…
2019-07-19 19:46 UTC2019-07N021936-002PED2019-03-15ea99ee380514…
2019-07-19 19:46 UTC2019-07N021936-002NPP2020-02-15ea99ee380514…
2019-07-19 19:46 UTC2019-07N021936-002PED2020-08-15ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spiriva RespimatTIOTROPIUM BROMIDE INHALATION SPRAYBoehringer Ingelheim Pharmaceuticals, Inc.7b656b14-fcaa-2741-f6f0-e0be48971c022026-08-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021936
application number: NDA021936
ndc (product): 0597-0100

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0100Spiriva Respimattiotropium bromide inhalation sprayBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80798SUPPL 2025-01-02
80786SUPPL 2024-12-30
57726SUPPL2019-02-21
57701SUPPL2019-02-19
47252SUPPL2017-02-16
16602SUPPL2016-06-13
6490SUPPL2016-06-10
37907SUPPL2016-02-17
28878SUPPL2016-01-20
44659ORIG2015-07-02
42354ORIG2015-07-02
37906ORIG2014-09-26
6489ORIG2014-09-26
52375ORIG1900-01-01
51572ORIG1900-01-01
51571ORIG1900-01-01
51570ORIG1900-01-01