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Details for New Drug Application (NDA): 021747

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NDA 021747 describes COMBIVENT RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the COMBIVENT RESPIMAT profile page.

The generic ingredient in COMBIVENT RESPIMAT is albuterol sulfate; ipratropium bromide. There are thirty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

Summary for NDA: 021747

Tradename:
COMBIVENT RESPIMAT
Applicant:
Boehringer Ingelheim
Ingredient:
albuterol sulfate; ipratropium bromide
Patents:18
Formulation / Manufacturing:see details

Pharmacology for NDA: 021747

Suppliers and Packaging for NDA: 021747

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION 021747 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0024 0597-0024-02 1 CARTRIDGE in 1 CARTON (0597-0024-02) > 120 SPRAY, METERED in 1 CARTRIDGE
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION 021747 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0024 0597-0024-59 1 CARTRIDGE in 1 CARTON (0597-0024-59) > 60 SPRAY, METERED in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.1MG BASE/INH;0.02MG/INH
Approval Date:Oct 7, 2011TE: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: 021747

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20116,726,124► subscribe
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20115,405,084► subscribe
Boehringer Ingelheim
COMBIVENT RESPIMAT
albuterol sulfate; ipratropium bromide
SPRAY, METERED;INHALATION021747-001Oct 7, 20115,911,851► subscribe
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