Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091300
Company: APOTEX CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription AB 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
06/18/2013 ORIG-1 Approval

Label is not available on this site.

RILUZOLE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RILUTEK RILUZOLE 50MG TABLET;ORAL Prescription Yes AB 020599 COVIS PHARMA BV
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 204048 ALKEM LABS LTD
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 091300 APOTEX CORP
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 204430 DAITO PHARMS CO LTD
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 091394 GLENMARK PHARMS LTD
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 076173 IMPAX LABS
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 203042 MYLAN PHARMS INC
RILUZOLE RILUZOLE 50MG TABLET;ORAL Prescription No AB 091417 SUN PHARM INDS LTD

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