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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONABRLD, RS2004-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021395-001SPIRIVAEQ 0.018MG BASE/INHPOWDER / INHALATIONRLD, RS2004-01-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021395-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021395-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021395-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021395-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021395-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021395-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021395-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021395-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021395-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021395-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021395-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021395-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021395-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021395-001AB1a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021395-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 10 · 373 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021395-00180220822026-01-19U-1186Drug product2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021395-0018022082*PED2026-07-19Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021395-00180220822026-01-19U-1186Drug product2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021395-0018022082*PED2026-07-19Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021395-00180220822026-01-19U-1186Drug product2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021395-0018022082*PED2026-07-19Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-00180220822026-01-19U-1186Drug product2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-0018022082*PED2026-07-19Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-00176946762027-03-12Drug product2011-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-0017694676*PED2027-09-12Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021395-00190103232030-04-19Drug product2017-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-00180220822026-01-19U-1186Drug product2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-0018022082*PED2026-07-19Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-00176946762027-03-12Drug product2011-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-0017694676*PED2027-09-12Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021395-00190103232030-04-19Drug product2017-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-00180220822026-01-19U-1186Drug product2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-0018022082*PED2026-07-19Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-00176946762027-03-12Drug product2011-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-0017694676*PED2027-09-12Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021395-00190103232030-04-19Drug product2017-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-00180220822026-01-19U-1186Drug product2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-0018022082*PED2026-07-19Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-00176946762027-03-12Drug product2011-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-0017694676*PED2027-09-12Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021395-00190103232030-04-19Drug product2017-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-00180220822026-01-19U-1186Drug product2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-0018022082*PED2026-07-19Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-00176946762027-03-12Drug product2011-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-0017694676*PED2027-09-12Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021395-00190103232030-04-19Drug product2017-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-00180220822026-01-19U-1186Drug product2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-0018022082*PED2026-07-19Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-00176946762027-03-12Drug product2011-06-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-0017694676*PED2027-09-12Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021395-00190103232030-04-19Drug product2017-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021395-00180220822026-01-19U-1186Drug product2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021395-0018022082*PED2026-07-19Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N021395-00176946762027-03-12Drug product2011-06-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N021395-0017694676*PED2027-09-12Pediatric extensiond06236e962d9…

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