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Details for New Drug Application (NDA): 203108

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NDA 203108 describes STRIVERDI RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the STRIVERDI RESPIMAT profile page.

The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.

Summary for NDA: 203108

Tradename:
STRIVERDI RESPIMAT
Applicant:
Boehringer Ingelheim
Ingredient:
olodaterol hydrochloride
Patents:25

Pharmacology for NDA: 203108

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 203108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION 203108 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0192 0597-0192-28 1 CARTRIDGE in 1 CARTON (0597-0192-28) > 28 SPRAY, METERED in 1 CARTRIDGE
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION 203108 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0192 0597-0192-61 1 CARTRIDGE in 1 CARTON (0597-0192-61) > 60 SPRAY, METERED in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Jul 31, 2014TE: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: 203108

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 20145,964,416► subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 20147,104,470► subscribe
Boehringer Ingelheim
STRIVERDI RESPIMAT
olodaterol hydrochloride
SPRAY, METERED;INHALATION203108-001Jul 31, 20146,726,124► subscribe
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