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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218354
Company: LONG GROVE PHARMS

Products on ANDA 218354

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218354

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

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