U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216809
Company: GLAND PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/24/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

KETAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 HIKMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074549 HOSPIRA

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETALAR KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016812 PAR STERILE PRODUCTS
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076092 EUGIA PHARMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216809 GLAND PHARMA LTD
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074524 HIKMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074549 HOSPIRA
Back to Top