Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021875
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUVIGIL ARMODAFINIL 50MG TABLET;ORAL Prescription AB Yes No
NUVIGIL ARMODAFINIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
NUVIGIL ARMODAFINIL 150MG TABLET;ORAL Prescription AB Yes No
NUVIGIL ARMODAFINIL 250MG TABLET;ORAL Prescription AB Yes Yes
NUVIGIL ARMODAFINIL 200MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/07/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf
04/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf
06/28/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf
10/21/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
10/21/2010 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf
06/15/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf

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