SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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-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 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 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-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