Application 021936
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| 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 |
Orange Book products#
| 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#
| 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2015-09-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-001 | SPIRIVA RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-09-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-002 | SPIRIVA RESPIMAT | EQ 0.00125MG BASE/INH | SPRAY, METERED / INHALATION | RLD | 2015-09-15 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 7396341 | 2026-10-10 | Drug product, Delist requested | 2014-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 9027967 | 2027-03-31 | Drug product, Delist requested | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 7396341*PED | 2027-04-10 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 9027967*PED | 2027-09-30 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 7837235 | 2028-03-13 | Drug product, Delist requested | 2014-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 7837235*PED | 2028-09-13 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 8733341 | 2030-10-16 | Drug product, Delist requested | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021936-001 | 8733341*PED | 2031-04-16 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 7396341 | 2026-10-10 | Drug product, Delist requested | 2014-10-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 9027967 | 2027-03-31 | Drug product, Delist requested | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 7396341*PED | 2027-04-10 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 9027967*PED | 2027-09-30 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 7837235 | 2028-03-13 | Drug product, Delist requested | 2014-10-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 7837235*PED | 2028-09-13 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 8733341 | 2030-10-16 | Drug product, Delist requested | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021936-001 | 8733341*PED | 2031-04-16 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 7396341 | 2026-10-10 | Drug product, Delist requested | 2014-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 9027967 | 2027-03-31 | Drug product, Delist requested | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 7396341*PED | 2027-04-10 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 9027967*PED | 2027-09-30 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 7837235 | 2028-03-13 | Drug product, Delist requested | 2014-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 7837235*PED | 2028-09-13 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 8733341 | 2030-10-16 | Drug product, Delist requested | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021936-001 | 8733341*PED | 2031-04-16 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7284474 | 2024-08-26 | Drug product | 2014-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7284474*PED | 2025-02-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7396341 | 2026-10-10 | Drug product, Delist requested | 2014-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 9027967 | 2027-03-31 | Drug product, Delist requested | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7396341*PED | 2027-04-10 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 9027967*PED | 2027-09-30 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7837235 | 2028-03-13 | Drug product, Delist requested | 2014-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 7837235*PED | 2028-09-13 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 8733341 | 2030-10-16 | Drug product, Delist requested | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-001 | 8733341*PED | 2031-04-16 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-002 | 7284474 | 2024-08-26 | Drug product | 2015-10-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021936-002 | 7284474*PED | 2025-02-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021936-001 | 7284474*PED | 2025-02-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021936-001 | 7396341 | 2026-10-10 | Drug product, Delist requested | 2014-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021936-001 | 9027967 | 2027-03-31 | Drug product, Delist requested | 2015-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021936-001 | 7396341*PED | 2027-04-10 | Pediatric extension | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021936-001 | NPP | 2020-02-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-001 | PED | 2020-08-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-002 | PED | 2019-03-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-002 | NPP | 2020-02-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021936-002 | PED | 2020-08-15 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N021936-001 | NPP | 2020-02-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021936-001 | PED | 2020-08-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021936-002 | NPP | 2020-02-15 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021936-002 | PED | 2020-08-15 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021936-001 | NPP | 2020-02-15 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021936-001 | PED | 2020-08-15 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021936-002 | NPP | 2020-02-15 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021936-002 | PED | 2020-08-15 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021936-001 | NPP | 2020-02-15 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021936-001 | PED | 2020-08-15 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021936-002 | PED | 2019-03-15 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021936-002 | NPP | 2020-02-15 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021936-002 | PED | 2020-08-15 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021936-001 | NPP | 2020-02-15 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021936-001 | PED | 2020-08-15 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021936-002 | PED | 2019-03-15 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021936-002 | NPP | 2020-02-15 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021936-002 | PED | 2020-08-15 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021936-001 | NPP | 2020-02-15 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021936-001 | PED | 2020-08-15 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021936-002 | PED | 2019-03-15 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021936-002 | NPP | 2020-02-15 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021936-002 | PED | 2020-08-15 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Spiriva Respimat | TIOTROPIUM BROMIDE INHALATION SPRAY | Boehringer Ingelheim Pharmaceuticals, Inc. | 7b656b14-fcaa-2741-f6f0-e0be48971c02 | 2026-08-17 | Warnings, Adverse reactions | 021936 NDA021936 0597-0100 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80798 | SUPPL | 2025-01-02 |
| 80786 | SUPPL | 2024-12-30 |
| 57726 | SUPPL | 2019-02-21 |
| 57701 | SUPPL | 2019-02-19 |
| 47252 | SUPPL | 2017-02-16 |
| 16602 | SUPPL | 2016-06-13 |
| 6490 | SUPPL | 2016-06-10 |
| 37907 | SUPPL | 2016-02-17 |
| 28878 | SUPPL | 2016-01-20 |
| 44659 | ORIG | 2015-07-02 |
| 42354 | ORIG | 2015-07-02 |
| 37906 | ORIG | 2014-09-26 |
| 6489 | ORIG | 2014-09-26 |
| 52375 | ORIG | 1900-01-01 |
| 51572 | ORIG | 1900-01-01 |
| 51571 | ORIG | 1900-01-01 |
| 51570 | ORIG | 1900-01-01 |