Application 207070
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPIRIVA RESPIMAT | TIOTROPIUM BROMIDE | SPRAY;INHALATION | 2.5MCG | No | No |
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 | 207070 NDA207070 0597-0160 |
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 |
|---|---|---|---|---|---|
| 0597-0160 | Spiriva Respimat | tiotropium bromide inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0160 | Spiriva Respimat | tiotropium bromide inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0160 | Spiriva Respimat | tiotropium bromide inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0160 | Spiriva Respimat | tiotropium bromide inhalation spray | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |