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Drugs@FDA: FDA-Approved Drugs

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

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 Yes
EDARAVONE EDARAVONE 60MG/100ML (0.6MG/ML) SOLUTION;INTRAVENOUS Discontinued None No No

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.

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
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 217565 PHARMOBEDIENT
EDARAVONE EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216902 SANDOZ
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