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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215508
Company: HIKMA

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 INJECTION;SOLUTION None (Tentative Approval) 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 Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215508Orig1s000ltr.pdf

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 216902 SANDOZ
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