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Drugs@FDA: FDA-Approved Drugs

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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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/18/2021 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s019lbl.pdf
02/24/2021 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s018lbl.pdf
12/19/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/22250s017lbl.pdf
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 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.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-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
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