Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220602
Company: NEURORX

Products on ANDA 220602

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220602

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220602

KETAMINE HYDROCHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS; EQ 50MG BASE/5ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	219684	BAXTER HLTHCARE CORP
KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	220602	NEURORX