OMEPRAZOLE; SODIUM BICARBONATE | N021636 | SALIX PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5164 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that FDA declare omeprazole and sodium bicarbonate for oral suspension in a new 30 mg/packet; 1.68 mg/packet s | Suitability | 2024-11-05 | Denied | Hyman, Phelps & McNamara, P.C. |
Public Citizens Health Research Group - Citizen Petition 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, | Other | 2011-10-20 | Partially 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(omeprazole/sodium bicarbonate) that bears the phrase "immediate release" or uses the acr | 505(q) | 2008-12-02 | Withdrawn | — |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.
No patent or exclusivity listings for this strength.