Details for New Drug Application (NDA): 216809
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NDA 216809 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, and Hospira, and is included in five NDAs. It is available from nine 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 216809
| Tradename: | KETAMINE HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | ketamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216809
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 216809
Suppliers and Packaging for NDA: 216809
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETAMINE HYDROCHLORIDE | ketamine hydrochloride | INJECTABLE;INJECTION | 216809 | ANDA | Sagent Pharmaceuticals | 25021-682 | 25021-682-20 | 10 VIAL in 1 CARTON (25021-682-20) / 20 mL in 1 VIAL |
| KETAMINE HYDROCHLORIDE | ketamine hydrochloride | INJECTABLE;INJECTION | 216809 | ANDA | Sagent Pharmaceuticals | 25021-683 | 25021-683-10 | 10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Jan 24, 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 24, 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: | Jan 24, 2023 | TE: | AP | RLD: | No | ||||
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