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Details for New Drug Application (NDA): 021936

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NDA 021936 describes SPIRIVA RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the SPIRIVA RESPIMAT profile page.

The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

Summary for NDA: 021936

Tradename:
SPIRIVA RESPIMAT
Applicant:
Boehringer Ingelheim
Ingredient:
tiotropium bromide
Patents:19

Pharmacology for NDA: 021936

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 021936

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION 021936 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0100 0597-0100-28 1 CARTRIDGE in 1 CARTON (0597-0100-28) > 28 SPRAY, METERED in 1 CARTRIDGE
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION 021936 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0100 0597-0100-31 1 CARTRIDGE in 1 CARTON (0597-0100-31) > 28 SPRAY, METERED in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:5,964,416Patent Expiration:Oct 4, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,149,054Patent Expiration:Dec 16, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,176,442Patent Expiration:May 31, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021936

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 20145,964,416► subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20155,964,416► subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 20146,176,442► subscribe
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