Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207363
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;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
04/23/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207363Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

RUFINAMIDE

SUSPENSION;ORAL; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BANZEL RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription Yes AB 201367 EISAI INC
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 213410 ALKEM LABS LTD
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 211388 BIONPHARMA INC
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 207363 HIKMA
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 213457 LUPIN LTD

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