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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 016812


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NDA 016812 describes KETALAR, which is a drug marketed by Ph Health and is included in one NDA. It is available from two suppliers. Additional details are available on the KETALAR profile page.

The generic ingredient in KETALAR 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 016812
Tradename:KETALAR
Applicant:Ph Health
Ingredient:ketamine hydrochloride
Patents:0
Pharmacology for NDA: 016812
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 016812
Analgesics
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Suppliers and Packaging for NDA: 016812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812 NDA Henry Schein, Inc 0404-9880 0404-9880-20 1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL
KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812 NDA Par Health USA, LLC 42023-113 42023-113-10 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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