ALBUTEROL | N018473 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from McDermott, Will & Emery FDA-1997-P-0044 · 5 docket documents On June 26, 1997, McDermott, Will & Emery, on behalf of an unnamed client, filed a citizen petition requesting that the FDA designate Schering's Proventil Repetabs (albuterol sulfate extended release tablets, 4 mg base) as a second reference listed drug under 21 CFR § 10.25(a), 10.30, and 314.92, to | 505(q) | 2017-08-30 | Granted | McDermott, Will & Emery |
Citizen Petition from Lachman Consultant Services, Inc. FDA-1996-P-0307 · 4 docket documents Lachman Consultant Services, Inc., filed this petition on behalf of a client requesting that the FDA amend the Orange Book to designate Schering's Proventil (albuterol) Metered Dose Inhaler, 0.09mg/INH, NDA #17-559, as a second reference-listed drug product to enable generic competition against this | 505(q) | 2017-04-05 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from 3M Drug Delivery Systems FDA-2015-P-1553 · 14 docket documents 3M Drug Delivery Systems filed this citizen petition on May 4, 2015, requesting that the FDA require all abbreviated new drug applications and 505(b)(2) applications for albuterol sulfate metered dose inhalers to include actuators that are either embossed or labeled to indicate use only with the acc | 505(q) | 2015-05-12 | Denied | 3M Drug Delivery Systems |
Teva Pharmaceutical Industries, Ltd. (Teva Respiratory, L.L.C.) - Citizen Pet... FDA-2013-P-0850 · 3 docket documents Teva Respiratory, LLC, a subsidiary of Teva Pharmaceutical Industries Ltd., filed this citizen petition on July 12, 2013, requesting that the FDA refrain from approving any abbreviated new drug application or 505(b)(2) application referencing ProAir HFA (albuterol sulfate) inhalation aerosol as the | 505(q) | 2013-07-25 | Partially Denied | — |
Paddock Laboratories, Inc., (Winston & Strawn LLP) - Citizen Petition FDA-2011-P-0486 · 4 docket documents Paddock Laboratories, Inc. filed a citizen petition on June 10, 2011, seeking paragraph IV patent certifications for numerous generic drug products including abacavir sulfate, various combination antiretroviral therapies, acyclovir sodium, albuterol sulfate formulations, alendronate sodium, and many | Other | 2011-07-19 | Granted | — |
Teva Pharmaceutical Industries Ltd. - Citizen Petition FDA-2010-P-0317 · 4 docket documents Teva Pharmaceutical Industries Ltd. filed this citizen petition pursuant to sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that FDA require any albuterol sulfate HFA inhalation aerosol drug product approved through the NDA or 505(b)(2) pathway to bear an approved | 505(q) | 2010-06-28 | Withdrawn | — |
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.
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