Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022250
Company: ACORDA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPYRA DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/22/2010 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf
10/13/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022250Orig1s013ltr.pdf
08/22/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/18/2013 SUPPL-8 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdf
12/21/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s007ltr.pdf
01/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s006ltr.pdf
07/20/2012 SUPPL-4 Labeling-Medication Guide, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s004ltr.pdf
07/20/2012 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
11/17/2011 SUPPL-2 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022250s002ltr.pdf
09/30/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf
10/13/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf
01/22/2013 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf
12/21/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf
07/20/2012 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
07/20/2012 SUPPL-4 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
07/20/2012 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
01/22/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf

AMPYRA

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPYRA DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022250 ACORDA
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206836 ACTAVIS LABS FL INC
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206811 AUROBINDO PHARMA LTD

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