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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 217858

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NDA 217858 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.

Summary for 217858

Tradename:	KETAMINE HYDROCHLORIDE
Applicant:	Caplin
Ingredient:	ketamine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 217858

Analgesics
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Aug 7, 2025	TE:	AP	RLD:	No

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