STERILE WATER IN PLASTIC CONTAINER

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.

FDA-2023-P-4331

Fresenius Kabi USA, LLC filed a suitability petition under 21 CFR 314.93 and Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for Sterile Water for Irrigation, USP in 250 mL and 1500 mL single dose flexible plastic containers, representing a change in strength and total

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.

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.

FDA-2019-P-6047

Fresenius Kabi USA, LLC filed this suitability petition pursuant to Section 505(j)(2)(C) requesting FDA approval to submit an Abbreviated New Drug Application for Sterile Water for Irrigation, USP in 250 mL and 1500 mL fill sizes in flexible plastic containers, representing a change in strength from