KETALAR

FDA-2025-P-3577

NRx Pharmaceuticals, Inc. filed this citizen petition on August 29, 2025, requesting that the FDA ban all ketamine products containing benzethonium chloride, a preservative the petitioner asserts is toxic and not generally recognized as safe and effective. NRx argues that benzethonium chloride is un

FDA-2025-P-3541

NeuroRx Pharmaceuticals, Inc. submitted a Suitability Petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that the FDA declare Ketamine Hydrochloride Injection, 50 mg/5 mL (10 mg/mL), suitable for submission as an ANDA, with the reference listed drug being KETALAR (NDA 016812) curren

FDA-2023-P-4287

Lachman Consulting Services Inc filed a citizen petition regarding Ketalar (ketamine hydrochloride) requesting that the FDA determine the suitability of the drug substance and formulation for use in abbreviated new drug applications or generic drug development.

FDA-2023-P-4287

Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA approval to pursue an ANDA for Ketamine Hydrochloride Injection USP in 0.5 mL and 1 mL single-dose preservative-free prefille

FDA-2019-P-4386

Fresenius Kabi USA, LLC filed a petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an Abbreviated New Drug Application for Ketamine Hydrochloride Injection in lower strengths (100 mg/10 mL and 50 mg/5 mL) compared to the listed drug KETALA

FDA-2019-P-4386

Fresenius Kabi USA, LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that Ketamine Hydrochloride Injection in strengths of 100 mg/10 mL and 50 mg/5 mL (both at 10 mg/mL concentration) be determined suitable for submission as an ANDA, c

FDA-2019-P-0114

Pfizer Innovative Health Global Regulatory Affairs and Hopira, Inc. filed a citizen petition regarding KETALAR (ketamine hydrochloride) injectable solution in three strengths (10 mg/mL, 50 mg/mL, and 100 mg/mL), which is approved under NDA 016812. The petition document provided appears to contain Or

FDA-1999-P-2420

Wildlife Laboratories, Inc. filed a suitability petition requesting permission to submit an ANADA for Ketanil 200 (Ketamine Hydrochloride Injection) at a concentration of 200mg/ml, which differs from pioneer products by strength of the active ingredient only, and requested a waiver of in-vivo bioequ

FDA-2001-P-0565

Bioniche Pharma (Canada) Ltd. submitted an ANDA suitability petition under 21 CFR section 314.93 requesting permission to file an ANDA for Ketamine Hydrochloride Injection, USP 100 mg/mL, which differs from the reference listed drug Ketalar by having a 10 mL vial size instead of 5 mL, and also reque