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Abbreviated New Drug Application (ANDA): 204964
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUFINAMIDE RUFINAMIDE 100MG TABLET;ORAL Prescription None No No
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
08/17/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204964Orig1s000ltr.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 204993 HETERO LABS LTD III
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 204988 HIKMA
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 204964 LUPIN LTD
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 205095 MYLAN

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 204993 HETERO LABS LTD III
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 204988 HIKMA
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 204964 LUPIN LTD
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 205095 MYLAN
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