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Generated: April 30, 2017

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Details for New Drug Application (NDA): 076092

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NDA 076092 describes KETAMINE HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, Hospira, and Mylan Institutional, and is included in three NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.

Summary for NDA: 076092

Formulation / Manufacturing:see details

Pharmacology for NDA: 076092

Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 076092

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ketamine hydrochloride
INJECTABLE;INJECTION 076092 ANDA Mylan Institutional LLC 67457-001 67457-001-10 10 VIAL in 1 CARTON (67457-001-10) > 10 mL in 1 VIAL (67457-001-00)
ketamine hydrochloride
INJECTABLE;INJECTION 076092 ANDA Mylan Institutional LLC 67457-108 67457-108-10 10 VIAL in 1 CARTON (67457-108-10) > 10 mL in 1 VIAL (67457-108-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Sep 30, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Dec 28, 2001TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Oct 25, 2002TE:APRLD:No

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