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Details for New Drug Application (NDA): 206756
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The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride; tiotropium bromide profile page.
Summary for 206756
Tradename: | STIOLTO RESPIMAT |
Applicant: | Boehringer Ingelheim |
Ingredient: | olodaterol hydrochloride; tiotropium bromide |
Patents: | 15 |
Generic Entry Opportunity Date for 206756
Generic Entry Date for 206756*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 206756
Mechanism of Action | Cholinergic Antagonists Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 206756
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0155 | 0597-0155-28 | 1 CARTRIDGE in 1 CARTON (0597-0155-28) > 28 SPRAY, METERED in 1 CARTRIDGE |
STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0155 | 0597-0155-31 | 1 CARTRIDGE in 1 CARTON (0597-0155-31) > 28 SPRAY, METERED in 1 CARTRIDGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;INHALATION | Strength | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | ||||
Approval Date: | May 21, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 5, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Aug 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | Dec 7, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 206756
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