Drugs@FDA: FDA Approved Drug Products

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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NUVIGIL ARMODAFINIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf
04/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf
02/09/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/23/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/05/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/13/2012 SUPPL-17 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
01/13/2012 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
10/21/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
06/28/2013 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf
10/21/2010 SUPPL-8 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
03/26/2009 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf
10/21/2010 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf
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

NUVIGIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 50MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 50MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 150MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 250MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 206069 AUROBINDO PHARMA LTD
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 200751 LUPIN LTD
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 200043 MYLAN PHARMS INC
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Prescription No AB 202768 NATCO PHARMA LTD
NUVIGIL ARMODAFINIL 200MG TABLET;ORAL Prescription Yes AB 021875 CEPHALON

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