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Details for New Drug Application (NDA): 206756

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NDA 206756 describes STIOLTO RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are twenty-six patents protecting this drug. Additional details are available on the STIOLTO RESPIMAT profile page.

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 NDA: 206756

Pharmacology for NDA: 206756

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 0597-0155-61 1 CARTRIDGE in 1 CARTON (0597-0155-61) > 60 SPRAY, METERED in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Approval Date:May 21, 2015TE:RLD:Yes
Patent:5,964,416Patent Expiration:Oct 4, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,149,054Patent Expiration:Dec 19, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,176,442Patent Expiration:Oct 4, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 206756

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20155,964,416► subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,104,470► subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,246,615► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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