SODIUM CHLORIDE 14.6%

FDA-2021-P-0211

Fresenius Kabi USA LLC filed a suitability petition regarding NDA 018897, requesting FDA evaluation of the reference listed drug labeling to determine suitability for use as a reference standard for generic drug applications. The petition seeks confirmation that the existing labeling of this referen

FDA-2021-P-0211

Fresenius Kabi USA, LLC filed a suitability petition pursuant to 21 CFR 314.93 and Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for Sodium Chloride Injection 23.4% in a pharmacy bulk package format with an increased total drug content from 100 mL to 200 mL in plastic

FDA-2020-P-2304

Fresenius Kabi USA, LLC submitted this citizen petition under 21 CFR 314.161 requesting that the FDA determine whether Sodium Chloride 14.6% 50mEq/20mL in plastic containers under NDA 018897 (held by Hospira, Inc.) was withdrawn from the marketplace for reasons other than safety or efficacy, to perm

FDA-2020-P-2304

Fresenius Kabi USA, LLC filed a citizen petition requesting that the FDA correct or review the Orange Book listing for Sodium Chloride 14.6% under NDA 018897, addressing apparent discrepancies in the drug's patent or exclusivity information maintained in the Orange Book database.

FDA-2016-P-2568

Fresenius Kabi USA, LLC filed this citizen petition on August 31, 2016, requesting that the FDA designate Sodium Chloride in Plastic Container (2.5 mEq/mL) by Hospira (NDA 018897) as the reference listed drug to enable applicants to submit abbreviated new drug applications for this multi-source prod