SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

FDA-2021-P-0568 · 2 docket documents

BAMF Health, Inc. filed this Section 505(j)(2)(C) suitability petition on June 15, 2021, requesting that the FDA amend the sodium chloride concentration in the citrate buffer of Fludeoxyglucose F 18 Injection from 4.5 mg/mL to 6.5 mg/mL to allow submission of an ANDA referencing NDA 21-870, citing t

FDA-2021-P-0211 · 6 docket documents

Fresenius Kabi USA LLC filed a suitability petition regarding the Orange Book listing of sodium chloride, seeking FDA determination on the appropriateness of the current listing for this pharmaceutical product.

FDA-2018-P-4281 · 5 docket documents

Fresenius Kabi USA LLC submitted an amendment to a suitability petition (FDA-2018-P-4281) on November 7, 2018, proposing a package insert for Sodium Chloride Injection, USP, 23.4% in a pharmacy bulk package formulation intended for dilution and intravenous use as an additive in parenteral fluid ther

FDA-2019-P-6048 · 5 docket documents

Fresenius Kabi USA, LLC filed a petition regarding the Orange Book listing of Sodium Chloride 0.9% Irrigation USP, challenging its suitability classification and requesting that the FDA reconsider or modify the regulatory status of this irrigation solution product in the Orange Book.

FDA-2011-P-0846 · 6 docket documents

Jubilant HollisterStier submitted this suitability petition under 21 CFR 314.93 and Section 505(j)(2)(c) requesting FDA declare that 0.9% Sodium Chloride Injection USP in various fill volumes (0.5mL, 2.5mL, 3mL, and 10mL) in vials is suitable for submission as an ANDA, with the reference listed drug

FDA-1987-P-0042 · 3 docket documents

LyphoMed, Inc. filed this petition under 21 CFR 314.110(f) and the Drug Price Competition and Patent Term Restoration Act of 1984 requesting permission to submit an abbreviated new drug application for Sodium Chloride Injection, USP, 0.9% in a 100 mL plastic vial package size, citing patient safety

FDA-2009-P-0565 · 7 docket documents

Baxter Healthcare Corporation submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit filing of an Abbreviated New Drug Application (ANDA) for 0.9% Sodium Chloride Injection, USP (9 mg/mL) in a 2 mL vial, which would differ from t

FDA-2006-P-0400 · 5 docket documents

Beckloff Associates, Inc. filed a suitability petition on June 30, 2006, requesting FDA approval for 3-, 5-, 15-, and 30-mL presentations of 0.9% Sodium Chloride Injection, USP as suitable for use as a reference listed drug, with the package insert from Hospira, Inc. provided as supporting documenta

FDA-2006-P-0084 · 6 docket documents

Beckloff Associates filed a citizen petition regarding Hospira's Sodium Chloride 0.9% in Plastic Container (NDA 419217), an injectable solution approved on July 13, 1984, though the specific regulatory action requested is not detailed in the provided documentation excerpt.

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