Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020717
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVIGIL MODAFINIL 100MG TABLET;ORAL Prescription AB Yes No
PROVIGIL MODAFINIL 200MG TABLET;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
12/24/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20717ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020717A_Provigil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/13/2012 SUPPL-41 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-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf
01/15/2015 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf
01/15/2015 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020717Orig1s037,s038ltr.pdf
10/21/2010 SUPPL-36 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf
10/21/2010 SUPPL-34 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf
10/21/2010 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020717s030,s034,s036ltr.pdf
06/15/2007 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/13/2006 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/07/2006 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/17/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020717s020ltr.pdf
08/17/2007 SUPPL-18 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
03/08/2006 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/08/2005 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/26/2005 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/2004 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/17/2007 SUPPL-13 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
04/06/2004 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/22/2004 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/2003 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/29/2003 SUPPL-9 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scf009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S009_PROVIGIL_TABS.pdf
01/23/2004 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-008_provigil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20717se1-008ltr.pdf
04/16/2003 SUPPL-6 Manufacturing (CMC)-Packaging Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20717scp006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020717_S006_PROVIGIL_TABS.pdf
01/23/2004 SUPPL-5 Labeling

Label is not available on this site.

11/05/2001 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020717_S004_PROVIGIL_TABS_AP.pdf
09/19/2000 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S003_PROVIGIL_TABS_AP.pdf
05/17/2000 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020717_S002_PROVIGIL_TABS_AP.pdf
12/14/1999 SUPPL-1 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020717_S001_PROVIGIL_TABS_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/15/2015 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
01/15/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf
10/21/2010 SUPPL-36 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-34 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
10/21/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036lbl.pdf
08/17/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
08/17/2007 SUPPL-18 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
08/17/2007 SUPPL-13 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf
01/23/2004 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20717se1-008_provigil_lbl.pdf
12/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20717lbl.pdf

PROVIGIL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 202700 ALEMBIC PHARMS LTD
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 077667 APOTEX INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 207196 APPCO PHARMA LLC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 202566 AUROBINDO PHARMA LTD
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 090543 HIKMA PHARMS
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 076594 MYLAN PHARMS INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 078963 ORCHID HLTHCARE
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 076715 WATSON LABS INC
MODAFINIL MODAFINIL 100MG TABLET;ORAL Prescription No AB 209966 ZYDUS PHARMS USA INC
PROVIGIL MODAFINIL 100MG TABLET;ORAL Prescription Yes AB 020717 CEPHALON

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 202700 ALEMBIC PHARMS LTD
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 077667 APOTEX INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 207196 APPCO PHARMA LLC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 202566 AUROBINDO PHARMA LTD
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 090543 HIKMA PHARMS
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 076594 MYLAN PHARMS INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 078963 ORCHID HLTHCARE
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 076715 WATSON LABS INC
MODAFINIL MODAFINIL 200MG TABLET;ORAL Prescription No AB 209966 ZYDUS PHARMS USA INC
PROVIGIL MODAFINIL 200MG TABLET;ORAL Prescription Yes AB 020717 CEPHALON

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