Details for New Drug Application (NDA): 215808
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NDA 215808 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, and Baxter Hlthcare Corp, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the KETAMINE HYDROCHLORIDE profile page.
The generic ingredient in KETAMINE HYDROCHLORIDE is ketamine hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
The generic ingredient in KETAMINE HYDROCHLORIDE is ketamine hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
Summary for 215808
| Tradename: | KETAMINE HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ketamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215808
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 215808
Suppliers and Packaging for NDA: 215808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETAMINE HYDROCHLORIDE | ketamine hydrochloride | INJECTABLE;INJECTION | 215808 | ANDA | Fresenius Kabi USA, LLC | 65219-184 | 65219-184-20 | 10 VIAL in 1 TRAY (65219-184-20) / 20 mL in 1 VIAL (65219-184-01) |
| KETAMINE HYDROCHLORIDE | ketamine hydrochloride | INJECTABLE;INJECTION | 215808 | ANDA | Fresenius Kabi USA, LLC | 65219-186 | 65219-186-05 | 10 VIAL in 1 TRAY (65219-186-05) / 5 mL in 1 VIAL (65219-186-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Jan 13, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/ML | ||||
| Approval Date: | Jan 13, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Apr 18, 2025 | TE: | AP | RLD: | No | ||||
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