Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076092
Company: EUGIA PHARMA

Products on ANDA 076092

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076092

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
06/23/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 076092

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	ENDO OPERATIONS
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	ENDO OPERATIONS
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	ENDO OPERATIONS
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