olodaterol / tiotropium Metered Dose Inhaler
- Brand(s)
- Stiolto
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Boehringer Ingelheim Pharmaceuticals, Inc. (2015-06-25)
- Oldest Current Product
- 2015-05-21
- License(s)
- NDA
- RxNORM
- METERED DOSE INHALER\OLODATEROL:TIOTROPIUM
- FDAOB
- INHALATION\SPRAY, METERED\OLODATEROL HYDROCHLORIDE: TIOTROPIUM BROMIDE\rdfq
- SPL Active
- RESPIRATORY (INHALATION)\SPRAY, METERED\OLODATEROL HYDROCHLORIDE: TIOTROPIUM BROMIDE MONOHYDRATE
- SPL Moiety
- RESPIRATORY (INHALATION)\SPRAY, METERED\OLODATEROL: TIOTROPIUM
product(s) by strength(s)
olodaterol 0.0025 mg/actuat / tiotropium 0.0025 mg/actuat metered dose inhaler
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 005970155 | Stiolto | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 2015-05-21 | OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE | RESPIRATORY (INHALATION) | SPRAY, METERED | NDA206756 | 01e15aee-40e0-23f3-537f-c96dd63e2cb1 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA206756 | STIOLTO RESPIMAT | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 2015-05-21 | p6726124, SUBSTANCE p7104470, SUBSTANCE p7786111, SUBSTANCE p7246615, SUBSTANCE p7056916, SUBSTANCE p7837235, SUBSTANCE p6988496, SUBSTANCE p7396341, SUBSTANCE p7988001, SUBSTANCE p6176442, SUBSTANCE p7727984 p7284474, SUBSTANCE p6149054, SUBSTANCE p5964416, SUBSTANCE p7896264, SUBSTANCE p6977042, SUBSTANCE p8044046, TREATMENT OF COPD p8733341, SUBSTANCE p6846413, SUBSTANCE p9027967, SUBSTANCE pRE39820, TREATMENT OF COPD, SUBSTANCE p8034809, TREATMENT OF COPD p7220742, TREATMENT OF RESPIRATORY COMPLAINTS, SUBSTANCE p7491719, SUBSTANCE p6453795, SUBSTANCE p7802568, SUBSTANCE | NEW CHEMICAL ENTITY [2019-07-31] NEW COMBINATION [2018-05-21] | NDA206756_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA206756_001 | RX | OLODATEROL HYDROCHLORIDE (EQ 0.0025MG BASE/INH), TIOTROPIUM BROMIDE (EQ 0.0025MG BASE/INH) | SPRAY, METERED | True | 2015-05-21 | STIOLTO RESPIMAT |
patent(s)
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 01e15aee-40e0-23f3-537f-c96dd63e2cb1 (view SPL) | These highlights do not include all the information needed to use STIOLTO RESPIMAT safely and effectively. See full prescribing information for STIOLTO RESPIMAT. STIOLTO RESPIMAT (tiotropium bromide and olodaterol) inhalation spray, for oral inhalation use Initial U.S. Approval: 2015 | prescription | Human Prescription | Boehringer Ingelheim Pharmaceuticals, Inc. | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2015-06-25 | 2 | 005970155 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII