Application 021395
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPIRIVA | TIOTROPIUM BROMIDE | POWDER;INHALATION | EQ 0.018MG BASE/INH | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021395-001 | SPIRIVA | TIOTROPIUM BROMIDE | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021395-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 |
| N021395-001 | 8022082*PED | 2026-07-19 | 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 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | RLD, RS | 2004-01-30 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021395-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021395-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021395-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021395-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021395-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021395-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021395-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021395-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021395-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021395-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021395-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021395-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021395-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021395-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021395-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021395-001 | AB | 1 | a67488948f0b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021395-001 | AB | 1 | a50c72e98297… |
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 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | 7694676 | 2027-03-12 | Drug product | 2011-06-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | 7694676*PED | 2027-09-12 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021395-001 | 9010323 | 2030-04-19 | Drug product | 2017-04-20 | d8e5a09893c0… |
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 HandiHaler | TIOTROPIUM BROMIDE | Boehringer Ingelheim Pharmaceuticals, Inc. | 820839ef-e53d-47e8-a3b9-d911ff92e6a9 | 2025-11-10 | Warnings, Adverse reactions | 021395 NDA021395 0597-0075 |
| Spiriva HandiHaler | TIOTROPIUM BROMIDE | A-S Medication Solutions | c6343458-617b-41ed-8e96-763e91dc8e90 | 2025-09-02 | Warnings, Adverse reactions | 021395 NDA021395 |
| Spiriva HandiHaler | TIOTROPIUM BROMIDE | A-S Medication Solutions | ba462261-734a-4e9f-a5c0-5c676bc56a2e | 2023-02-06 | Warnings, Adverse reactions | 021395 NDA021395 50090-4248 |
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 |
|---|---|---|---|---|---|
| 0597-0075 | Spiriva | TIOTROPIUM BROMIDE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0075 | Spiriva | TIOTROPIUM BROMIDE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0075 | Spiriva | TIOTROPIUM BROMIDE | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 50090-4248 | Spiriva | TIOTROPIUM BROMIDE | A-S Medication Solutions | NDA | Current |
| 50090-4414 | Spiriva | TIOTROPIUM BROMIDE | A-S Medication Solutions | NDA | Current |
| 50090-4414 | Spiriva | TIOTROPIUM BROMIDE | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80802 | SUPPL | 2025-01-02 |
| 80801 | SUPPL | 2025-01-02 |
| 52280 | SUPPL | 2018-02-02 |
| 52255 | SUPPL | 2018-02-01 |
| 5248 | SUPPL | 2016-06-24 |
| 15360 | SUPPL | 2015-12-15 |
| 5247 | SUPPL | 2015-12-14 |
| 42136 | SUPPL | 2013-06-03 |
| 5246 | SUPPL | 2011-08-01 |
| 15359 | SUPPL | 2011-07-29 |
| 27662 | SUPPL | 2009-12-24 |
| 15358 | SUPPL | 2009-12-18 |
| 15356 | SUPPL | 2009-03-19 |
| 5245 | SUPPL | 2009-03-19 |
| 36814 | SUPPL | 2008-11-18 |
| 27661 | SUPPL | 2008-11-18 |
| 27660 | SUPPL | 2008-06-25 |
| 27659 | SUPPL | 2006-12-28 |
| 5244 | SUPPL | 2006-12-28 |
| 15357 | SUPPL | 2006-12-14 |
| 15355 | SUPPL | 2006-12-14 |
| 27658 | SUPPL | 2006-09-25 |
| 36813 | SUPPL | 2006-09-21 |
| 36812 | SUPPL | 2004-08-25 |
| 27657 | SUPPL | 2004-08-25 |
| 23653 | ORIG | 2004-07-13 |
| 21633 | ORIG | 2004-05-06 |
| 5243 | ORIG | 2004-03-16 |
| 15354 | ORIG | 2004-03-03 |