Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206314
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FELBAMATE FELBAMATE 600MG/5ML 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
06/16/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

FELBAMATE

SUSPENSION;ORAL; 600MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELBAMATE FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription No AB 202385 AMNEAL PHARMS
FELBAMATE FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription No AB 206314 TARO
FELBAMATE FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription No AB 211333 VISTAPHARM
FELBATOL FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription Yes AB 020189 MYLAN SPECIALITY LP

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