Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204615
Company: ACCORD HLTHCARE

Products on ANDA 204615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.