Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076092
Company: EUGIA PHARMA
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
12/28/2001 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76092.apdf.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076092_s000_KetamineTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2018 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/05/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/30/2008 SUPPL-9 Labeling

Label is not available on this site.

10/25/2002 SUPPL-2 Labeling

Label is not available on this site.

10/25/2002 SUPPL-1 Manufacturing (CMC)-New Strength

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

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 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 074524 HIKMA
KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074549 HOSPIRA

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