Drug application
STIOLTO RESPIMAT (OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE)
Drugs@FDA NDA 206756 · BOEHRINGER INGELHEIM
Key facts
| Drug name | STIOLTO RESPIMAT |
|---|---|
| Active ingredients | OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE |
| Application type | NDA |
| Application number | 206756 |
| Company | BOEHRINGER INGELHEIM |
| Dosage forms | SPRAY, METERED, INHALATION |
| Strength | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | May 21, 2015 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: