SODIUM CHLORIDE 0.9%

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-2018-P-3176

Medefil Inc. submitted this citizen petition on August 15, 2018, requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for its NDA 202832, Sodium Chloride Injection, USP, 0.9%, to designate the product as therapeutically equivalent to Hospira's NDA 01880

FDA-2012-P-1043

Foley & Lardner LLP filed this citizen petition on behalf of Medefil's Inc. requesting that the FDA designate Sodium Chloride Injection, USP, 0.9% in prefilled plastic syringes, NDA 202832, as a second reference listed drug in the Orange Book to permit the filing of abbreviated new drug applications

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.