KETAMINE HYDROCHLORIDE | N016812 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from NRx Pharmaceuticals, Inc. FDA-2025-P-3577 · 5 docket documents 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 | 505(q) | 2025-09-05 | Open | NRx Pharmaceuticals, Inc. |
Suitability Petition from NRx Pharmaceuticals, Inc. FDA-2025-P-3541 · 6 docket documents 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submission as an ANDA, with the reference listed drug being KETALAR (NDA 016812) curren | Suitability | 2025-09-04 | Withdrawn | NRx Pharmaceuticals, Inc. |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2023-P-4287 · 8 docket documents 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 | Granted | Lachman Consulting Services, Inc. |
Citizen Petition from Fresenius Kabi USA, LLC FDA-2019-P-4386 · 4 docket documents 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 | Other | 2019-09-19 | Granted | Fresenius Kabi USA, LLC |
Citizen Petition from Pfizer Innovative Health Global Regulatory Affairs, Ho... FDA-2019-P-0114 · 2 docket documents 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, Hopira, Inc. |
Citizen Petition from Wildlife Labs, Inc. FDA-1999-P-2420 · 10 docket documents 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, Inc. |
Citizen Petition from Bioniche Pharma (Canada) Ltd. FDA-2001-P-0565 · 6 docket documents 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.
Highest NADAC/Unit
$0.6682
per ml
Lowest NADAC/Unit
$0.6682
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42023011410KETALAR 500 MG/10 ML VIAL | $0.6682 | ML | Brand | $0.5397 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.