Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020717
Company: NUVO PHARMS
Company: NUVO PHARMS
| 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.html |
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 | REMS-Proposal, 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 | |
| 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 | REMS-Proposal | 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-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 |
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 077667 | APOTEX |
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 207196 | APPCO |
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 202566 | AUROBINDO PHARMA LTD |
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 209966 | CADILA |
| MODAFINIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | No | AB | 078963 | ORBION PHARMS |
| PROVIGIL | MODAFINIL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020717 | NUVO PHARMS |
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 |
| MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 077667 | APOTEX |
| MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 207196 | APPCO |
| MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 202566 | AUROBINDO PHARMA LTD |
| MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 209966 | CADILA |
| MODAFINIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | No | AB | 078963 | ORBION PHARMS |
| PROVIGIL | MODAFINIL | 200MG | TABLET;ORAL | Prescription | Yes | AB | 020717 | NUVO PHARMS |