Application 203108
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STRIVERDI RESPIMAT | OLODATEROL HYDROCHLORIDE | SPRAY, METERED;INHALATION | EQ 0.0025MG BASE/INH | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203108-001 | STRIVERDI RESPIMAT | OLODATEROL HYDROCHLORIDE | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N203108-001 | STRIVERDI RESPIMAT | EQ 0.0025MG BASE/INH | SPRAY, METERED / INHALATION | RLD, RS | 2014-07-31 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 7896264 | 2025-05-26 | Drug product | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 7396341 | 2026-10-10 | U-1547 | Drug product | 2014-08-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 9027967 | 2027-03-31 | Drug product | 2015-09-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 7837235 | 2028-03-13 | Drug product | 2014-08-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203108-001 | 8733341 | 2030-10-16 | Drug product | 2015-09-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 7896264 | 2025-05-26 | Drug product | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 7396341 | 2026-10-10 | U-1547 | Drug product | 2014-08-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 9027967 | 2027-03-31 | Drug product | 2015-09-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 7837235 | 2028-03-13 | Drug product | 2014-08-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203108-001 | 8733341 | 2030-10-16 | Drug product | 2015-09-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7284474 | 2024-08-26 | Drug product | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7896264 | 2025-05-26 | Drug product | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7396341 | 2026-10-10 | U-1547 | Drug product | 2014-08-15 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 9027967 | 2027-03-31 | Drug product | 2015-09-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 7837235 | 2028-03-13 | Drug product | 2014-08-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203108-001 | 8733341 | 2030-10-16 | Drug product | 2015-09-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7284474 | 2024-08-26 | Drug product | 2014-08-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7220742 | 2025-05-12 | U-1547 | Drug substance, Drug product | 2014-08-15 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 8034809 | 2025-05-12 | U-1547 | 2014-08-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7896264 | 2025-05-26 | Drug product | 2014-08-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7396341 | 2026-10-10 | U-1547 | Drug product | 2014-08-15 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7727984 | 2027-01-19 | Drug substance | 2014-08-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 9027967 | 2027-03-31 | Drug product | 2015-09-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203108-001 | 7837235 | 2028-03-13 | Drug product | 2014-08-15 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N203108-001 | NCE | 2019-07-31 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N203108-001 | NCE | 2019-07-31 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N203108-001 | NCE | 2019-07-31 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N203108-001 | NCE | 2019-07-31 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Striverdi Respimat | OLODATEROL RESPIMAT INHALATION SPRAY | Boehringer Ingelheim Pharmaceuticals, Inc. | 5d9a5433-857e-44ea-b3d6-2a400ca0cef5 | 2025-01-03 | Warnings, Adverse reactions | 203108 NDA203108 0597-0192 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0597-0192 | Striverdi Respimat | olodaterol respimat inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0192 | Striverdi Respimat | olodaterol respimat inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0192 | Striverdi Respimat | olodaterol respimat inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0192 | Striverdi Respimat | olodaterol respimat inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80796 | SUPPL | 2025-01-02 |
| 80783 | SUPPL | 2024-12-30 |
| 58949 | SUPPL | 2019-06-04 |
| 58899 | SUPPL | 2019-05-31 |
| 53621 | SUPPL | 2018-04-05 |
| 53597 | SUPPL | 2018-04-03 |
| 52754 | ORIG | 2018-02-28 |
| 19426 | SUPPL | 2016-06-13 |
| 10162 | SUPPL | 2016-06-10 |
| 24428 | ORIG | 2014-09-08 |
| 22911 | ORIG | 2014-09-08 |
| 40264 | ORIG | 2014-08-01 |
| 32377 | ORIG | 2014-08-01 |