SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

FDA-2021-P-0568

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

Fresenius Kabi USA LLC filed a suitability petition requesting FDA approval of proposed labeling for Sodium Chloride PBP (parenteral bulk product) in connection with its drug product development. The petition seeks confirmation that the submitted labeling is suitable and acceptable for the sodium ch

FDA-2021-P-0211

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

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

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-2019-P-6048

Fresenius Kabi USA, LLC filed a petition regarding sodium chloride 0.9% irrigation solution, requesting FDA approval of a proposed package insert for this irrigation product. The petition seeks to establish the suitability and appropriate labeling for this sodium chloride irrigation solution under F

FDA-2019-P-6048

Fresenius Kabi USA, LLC filed a citizen petition requesting that the FDA establish sodium chloride 0.9% irrigation USP as a suitable reference listed drug for abbreviated new drug application purposes, addressing labeling and regulatory classification for this irrigation solution product.

FDA-2011-P-0846

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

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

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

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

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

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