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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074524
Company: HIKMA

Products on ANDA 074524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 074524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/07/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/03/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/03/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/11/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/03/2001	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/24/1999	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074524

KETAMINE HYDROCHLORIDE

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

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