Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022399
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HORIZANT GABAPENTIN ENACARBIL 600MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
HORIZANT GABAPENTIN ENACARBIL 300MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes 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
04/06/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022399s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/01/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s008ltr.pdf
12/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf
12/26/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf
03/27/2013 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022399Orig1s005.pdf
04/18/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s004ltr.pdf
06/06/2012 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022399Orig1s003.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf
03/27/2013 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf
12/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf
12/26/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf
06/06/2012 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf
04/18/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf
04/06/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf

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