Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219684
Company: BAXTER HLTHCARE CORP

Products on ANDA 219684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETAMINE HYDROCHLORIDE	KETAMINE HYDROCHLORIDE	EQ 100MG BASE/10ML (EQ 10MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.