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COMBIVENT

NDA

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | N020291 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Boehringer Ingelheim Pharmaceuticals, Inc. - Citizen Petition FDA-2006-P-0204 · 9 docket documents Boehringer Ingelheim Pharmaceuticals, Inc. filed this citizen petition on October 5, 2006, pursuant to 21 CFR sections 10.20 and 10.30, requesting that the FDA refrain from removing Combivent (ipratropium bromide and albuterol sulfate) inhalation aerosol from the list of essential uses of chlorofluo	Other	2008-06-20	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Crossover Study in the Treatment of Patients With COPD NCT00462540	Phase 3	Completed	Dey	100	2007-05 → 2007-10
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD NCT03480997	Phase 1	Completed	Pneuma Respiratory, Inc	46	2016-12-27 → 2017-04-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH;0.018MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Oct 24, 1996

No patent or exclusivity listings for this strength.