STERILE WATER FOR IRRIGATION | N017513 | OTSUKA ICU MEDICAL LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 | Open | Fresenius Kabi USA |
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 | Open | Fresenius Kabi USA |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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