SODIUM CHLORIDE | N019329 | ABRAXIS PHARMACEUTICAL PRODUCTS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - Amendment to Suitability Petition from Fresenius Kabi USA, LLC FDA-2018-P-4281 Fresenius Kabi USA, LLC submitted an amendment to a suitability petition on November 7, 2018, regarding Sodium Chloride Injection, USP, 23.4% under NDA 019329, which is the approved reference listed drug originally developed by Abraxis Pharmaceutical Products. The petition seeks FDA confirmation reg | Suitability | 2020-06-24 | Granted | Fresenius Kabi USA, LLC |
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-4281 Fresenius Kabi USA, LLC filed this citizen petition under 21 CFR 10.20, 10.30, and 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Sodium Chloride 23.4% Injection, USP suitable for submission as an ANDA in pharmacy bulk package sizes of 100 | Other | 2018-11-08 | Granted | Fresenius Kabi USA, LLC |
Citizen Petition from Gordon Johnston Regulatory Consultants, LLC FDA-2016-P-1363 Gordon Johnston Regulatory Consultants, LLC filed this petition on behalf of an interested party requesting that the FDA determine whether Sodium Chloride Injection, 23.4% in plastic containers (NDA 019329), held by Abraxis Pharmaceutical Products, was voluntarily withdrawn or withheld from sale for | 505(q) | 2016-05-27 | Granted | Gordon Johnston Regulatory Consultants, LLC |
APP Pharmaceuticals, LLC - Citizen Petition FDA-2009-P-0069 APP Pharmaceuticals, LLC filed this ANDA suitability petition under 21 CFR 10.20, 10.30, and 314.93 and Section 505(j)(2)(C) requesting approval to submit an ANDA for sodium chloride 23.4% injection in pharmacy bulk packages with increased total drug content of 100 mL and 200 mL volumes in plastic v | Other | 2009-02-17 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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