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NDA

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | N020950 | PHARMOBEDIENT CONSULTING LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from The Ritedose Corporation FDA-2020-P-0102 · 5 docket documents The Ritedose Corporation filed this citizen petition under 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate ANDA 202496 as the reference standard for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, 0.5 mg/3 mg per 3 mL, because the original referenc	505(q)	2020-01-08	Withdrawn	The Ritedose Corporation
Citizen Petition from REGCON Solutions FDA-2015-P-4916 · 5 docket documents REGCON Solutions filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Watson's Ipratropium Bromide and Albuterol Sulfate Inhalation Solution ANDA 077063 as a second reference-listed drug for the same s	505(q)	2015-12-23	Denied	REGCON Solutions

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

5 letters from Drugs@FDA

Date	Submission	Document
May 31, 2012	SUPPL -37	View Letter (PDF)
Mar 7, 2011	SUPPL -32	View Letter (PDF)
Jun 6, 2006	SUPPL -12	View Letter (PDF)
Oct 20, 2005	SUPPL -18	View Letter (PDF)
Mar 21, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Mar 21, 2001

No patent or exclusivity listings for this strength.