OMEPRAZOLE | N209400 | DEXCEL PHARMA TECHNOLOGIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alliance For Natural Health USA 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 | 505(q) | 2020-06-11 | Denied | Alliance For Natural Health USA |
Suitability Petition from Aurora Pharmaceutical LLC 2 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 | Suitability | 2017-02-28 | Open | Aurora Pharmaceutical LLC 2 |
Dinsmore & Shohl, LLP - Citizen Petition 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 | Other | 2010-12-20 | Granted | — |
Precision Consultants, Inc. - Citizen Petition 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 | Other | 2009-09-28 | Denied | — |
Mattingly, Stanger & Malur, P.C. - Citizen Petition 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 | Other | 2009-01-05 | Denied | — |
Procter & Gamble Company - Citizen Petition 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 | 505(q) Stay Request | 2008-12-30 | Denied | — |
Proctor & Gamble Company - Citizen Petition 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 | 505(q) | 2008-12-02 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4413
per ea
Lowest NADAC/Unit
$0.4413
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70000038101OMEPRAZOLE DR 20 MG ODT | $0.4413 | EA | Generic | — | 2026-06-17 |
| 70000038102OMEPRAZOLE DR 20 MG ODT | $0.4413 | EA | Generic | — | 2026-06-17 |
| 00113052055OMEPRAZOLE DR 20 MG ODT | $0.4413 | EA | Generic | — | 2026-06-17 |
| 00113052074GS OMEPRAZOLE DR 20 MG ODT | $0.4413 | EA | Generic | — | 2026-06-17 |
| 46122061604OMEPRAZOLE DR 20 MG ODT | $0.4413 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.