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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021395-001 | SPIRIVA | EQ 0.018MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2004-01-30 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 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 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021395-001 | 8022082 | 2026-01-19 | U-1186 | Drug product | 2011-10-24 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021395-001 | 8022082*PED | 2026-07-19 | Pediatric extension | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| 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 |
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 |