FDA ANDA 215808, KETAMINE HYDROCHLORIDE, FRESENIUS KABI USA, 01/13/2023

Contents: Approval letter and summary basis of approval

ANDA: 215808
Company: FRESENIUS KABI USA
Drug Name: KETAMINE HYDROCHLORIDE
Active Ingredients: KETAMINE HYDROCHLORIDE
Strength: EQ 50MG BASE/ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 01/13/2023
Marketing Status: Prescription
Submission Classification: ORIG-1

23 Pages