STERILE WATER FOR IRRIGATION | N017428 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Completeness Assessment Correspondence FDA-2023-P-4331 Fresenius Kabi USA, LLC filed a suitability petition requesting permission under 21 CFR 314.93(b) to submit an ANDA for Sterile Water for Irrigation in 250 mL and 1500 mL formulations. The FDA determined the petition complete on October 18, 2023, with a GDUFA III review goal date of April 18, 2024. | Suitability | 2023-10-19 | Denied | — |
Attachment 1- Orange Book Listing of Sterile Water for Irrigation USP re Suit... FDA-2023-P-4331 Fresenius Kabi USA, LLC filed a petition requesting that the FDA list Sterile Water for Irrigation USP in the Orange Book as a suitable product for pharmaceutical use, addressing regulatory recognition and listing requirements for this sterile solution. | Suitability | 2023-10-03 | Denied | Fresenius Kabi USA, LLC |
Attachment 2- Reference Listed Drug Labeling Sterile Water for Irrigation USP... FDA-2023-P-4331 Fresenius Kabi USA, LLC filed a petition requesting that the FDA establish Sterile Water for Irrigation USP as a suitable reference listed drug for purposes of demonstrating bioequivalence or establishing the appropriateness of an abbreviated new drug application under the ANDA pathway. | Suitability | 2023-10-03 | Denied | Fresenius Kabi USA, LLC |
Attachment 2 Reference Listed Drug Labeling Sterile Water for Irrigation USP ... FDA-2019-P-6047 Fresenius Kabi USA, LLC filed a petition requesting that the FDA designate Sterile Water for Irrigation USP as a suitable reference listed drug for purposes of abbreviated new drug application submissions. | Suitability | 2019-12-26 | Open | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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