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Generated: November 17, 2018

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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 twelve 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. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
Summary for 021936
Tradename:SPIRIVA RESPIMAT
Applicant:Boehringer Ingelheim
Ingredient:tiotropium bromide
Patents:12
Pharmacology for NDA: 021936
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 021936
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Sep 24, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 15, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Aug 15, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 24, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 021936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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