KETAMINE HYDROCHLORIDE | N016812 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from NRx Pharmaceuticals, Inc. 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 | Suitability | 2025-09-04 | Open | NRx Pharmaceuticals |
Attachment 2 KETALAR re Suitability Petition from Lachman Consulting Services... 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. | Suitability | 2023-10-03 | Open | Lachman Consulting Services Inc |
Suitability Petition from Lachman Consulting Services, Inc. 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 | Suitability | 2023-10-03 | Open | Lachman Consulting Services |
Suitability Petition Approval from FDA CDER to Fresenius Kabi USA, LLC 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 | Suitability | 2022-07-27 | Open | — |
Citizen Petition from Pfizer Innovative Health Global Regulatory Affairs, Ho... 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 | Other | 2019-01-08 | Open | Pfizer Innovative Health Global Regulatory Affairs |
Citizen Petition from Wildlife Labs, Inc. 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 | Other | 2017-05-01 | Denied | Wildlife Labs |
Citizen Petition from Bioniche Pharma (Canada) Ltd. 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 | Other | 2009-04-17 | Granted | Bioniche Pharma (Canada) Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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