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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020189
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FELBATOL FELBAMATE 400MG TABLET;ORAL Prescription AB Yes No
FELBATOL FELBAMATE 600MG TABLET;ORAL Prescription AB Yes Yes
FELBATOL FELBAMATE 600MG/5ML SUSPENSION;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/31/2012 SUPPL-27 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf
07/06/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf
07/06/2011 SUPPL-23 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf
04/23/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf
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