PRILOSEC

FDA-2020-P-1540 · 5 docket documents

Alliance for Natural Health USA filed this citizen petition requesting that the Food and Drug Administration issue a regulation requiring all manufacturers of proton pump inhibitor medications, including omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, and dexlansoprazole, to expan

FDA-2017-P-1225 · 4 docket documents

Aurora Pharmaceutical LLC submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act in February 2017 requesting FDA permission to file an abbreviated new animal drug application for Omeprazole Suspension 4.5% w/v, a generic version of the reference listed drug Gastro

FDA-2013-P-1286 · 3 docket documents

Procter & Gamble Company filed this citizen petition requesting that the FDA continue requiring consistent labeling across all over-the-counter proton pump inhibitors approved for frequent heartburn treatment, substantially equivalent to that approved for Prilosec OTC, including statements about del

FDA-2011-P-0741 · 4 docket documents

Public Citizen's Health Research Group filed this citizen petition pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56 requesting that the FDA immediately add black box warnings and other enhanced safety labeling to all proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid,

FDA-2010-P-0638 · 6 docket documents

Dinsmore & Shohl, LLP filed a petition on behalf of an unnamed client under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new palatable tablet dosage form of omeprazole for horses is suitable for submission as an abbreviated new animal drug applica

FDA-2009-P-0450 · 6 docket documents

Precision Consultants, Inc. filed this suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an abbreviated new animal drug application (ANADA) for omeprazole palatable tablets for horses at a new strength of 570 mg per tablet, dif

FDA-2003-P-0224 · 4 docket documents

The law firm Mattingly, Stanger & Malur, P.C. filed this citizen petition under 21 CFR 10.30 and 10.35(b) requesting that the FDA amend its NDA approval for Prilosec OTC (omeprazole magnesium), a nonprescription heartburn treatment approved on June 20, 2003, to require marketing under a different br

FDA-2008-P-0654 · 7 docket documents

Procter & Gamble Company filed this citizen petition pursuant to 21 CFR 10.30 and 21 USC 355 requesting that FDA refrain from approving an over-the-counter version of Zegerid (omeprazole/sodium bicarbonate) if it bears the phrase "immediate release" or "IR" on the label, lacks a prominent disclaimer

FDA-2008-P-0599 · 7 docket documents

The Procter & Gamble Company filed this citizen petition pursuant to 21 C.F.R. § 10.30 and 21 U.S.C. § 355, requesting that FDA refrain from granting effective approval of an over-the-counter version of Zegerid (omeprazole/sodium bicarbonate) that bears the phrase "immediate release" or uses the acr