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 six 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-eight 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 021747

Tradename:	COMBIVENT RESPIMAT
Applicant:	Boehringer Ingelheim
Ingredient:	albuterol sulfate; ipratropium bromide
Patents:	6

Pharmacology for NDA: 021747

Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;INHALATION			Strength	EQ 0.1MG BASE/INH;0.02MG/INH
Approval Date:	Oct 7, 2011	TE:		RLD:	Yes
Patent:	7,284,474	Patent Expiration:	Aug 26, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,396,341	Patent Expiration:	Oct 10, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,837,235	Patent Expiration:	Mar 13, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021747

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,453,795	⤷ Subscribe
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	7,246,615	⤷ Subscribe
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,977,042	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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