Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205095
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription AB No No
RUFINAMIDE RUFINAMIDE 400MG 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
05/16/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf

RUFINAMIDE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BANZEL RUFINAMIDE 200MG TABLET;ORAL Prescription Yes AB 021911 EISAI INC
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 205075 GLENMARK PHARMS LTD
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 205095 MYLAN PHARMS INC
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 204988 WEST-WARD PHARMS INT

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BANZEL RUFINAMIDE 400MG TABLET;ORAL Prescription Yes AB 021911 EISAI INC
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 205075 GLENMARK PHARMS LTD
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 205095 MYLAN PHARMS INC
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 204988 WEST-WARD PHARMS INT

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