Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216199
Company: GLAND PHARMA LTD

Products on ANDA 216199

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216199

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.

Therapeutic Equivalents for ANDA 216199

EDARAVONE

SOLUTION;INTRAVENOUS; 30MG/100ML (0.3MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216199	GLAND PHARMA LTD
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215508	HIKMA
EDARAVONE	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218354	LONG GROVE PHARMS
RADICAVA	EDARAVONE	30MG/100ML (0.3MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209176	MITSUBISHI TANABE

SOLUTION;INTRAVENOUS; 60MG/100ML (0.6MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215917	DR REDDYS
EDARAVONE	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216199	GLAND PHARMA LTD
RADICAVA	EDARAVONE	60MG/100ML (0.6MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209176	MITSUBISHI TANABE