Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201680
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription AB No No
FELBAMATE FELBAMATE 600MG 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
09/13/2011 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201680s000ltr.pdf

FELBAMATE

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 204595 ALVOGEN
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 201680 AMNEAL PHARMS
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 202284 ANI PHARMS INC
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 208970 CADILA
FELBAMATE FELBAMATE 400MG TABLET;ORAL Prescription No AB 207093 TARO
FELBATOL FELBAMATE 400MG TABLET;ORAL Prescription Yes AB 020189 MYLAN SPECIALITY LP

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 204595 ALVOGEN
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 201680 AMNEAL PHARMS
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 202284 ANI PHARMS INC
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 208970 CADILA
FELBAMATE FELBAMATE 600MG TABLET;ORAL Prescription No AB 207093 TARO
FELBATOL FELBAMATE 600MG TABLET;ORAL Prescription Yes AB 020189 MYLAN SPECIALITY LP

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