SODIUM BICARBONATE

FDA-2009-P-0396 · 5 docket documents

The law firm Olsson Frank Weeda Terman Bode Matz PC filed this petition on August 18, 2009, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA find sodium bicarbonate injection suitable for submission as an abbreviated new drug application in two st

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

FDA-2008-P-0412 · 6 docket documents

Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and