Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021299
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEXEVA | PAROXETINE MESYLATE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| PEXEVA | PAROXETINE MESYLATE | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| PEXEVA | PAROXETINE MESYLATE | EQ 30MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| PEXEVA | PAROXETINE MESYLATE | EQ 40MG BASE | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/2003 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Label (PDF) Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21299ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299_Paroxetine.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021299s035s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021299Orig1s035,s038ltr.pdf | |
| 09/20/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021299s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021299Orig1s037ltr.pdf | |
| 08/18/2023 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021299s035s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021299Orig1s035,s038ltr.pdf | |
| 01/04/2017 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021299Orig1s033ltr.pdf | |
| 07/18/2014 | SUPPL-32 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021299Orig1s032ltr.pdf | |
| 12/31/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021299s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021299Orig1s031ltr.pdf | |
| 11/26/2012 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2012 | SUPPL-29 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf |
| 12/18/2012 | SUPPL-28 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf |
| 12/18/2012 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf |
| 04/28/2011 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021299s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021299s024ltr.pdf | |
| 01/30/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021299s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021299s023ltr.pdf | |
| 01/29/2010 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021299s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021299s022ltr.pdf | |
| 03/06/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021299s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021299s021ltr.pdf | |
| 10/05/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s020ltr.pdf | |
| 08/03/2007 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021299s019ltr.pdf | |
| 12/09/2006 | SUPPL-18 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf | |
| 12/09/2006 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf | |
| 12/09/2006 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021299s016, s017, s018ltr.pdf | |
| 01/12/2005 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21299s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21299s013ltr.pdf | |
| 08/30/2004 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21299s007ltr.pdf |
| 08/21/2003 | SUPPL-1 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21299slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021299_S001_PEXEVA_TABLETS.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021299s035s038lbl.pdf | |
| 08/18/2023 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021299s035s038lbl.pdf | |
| 09/20/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021299s037lbl.pdf | |
| 12/31/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021299s031lbl.pdf | |
| 01/04/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf | |
| 01/04/2017 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf | |
| 07/18/2014 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf | |
| 04/28/2011 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021299s024lbl.pdf | |
| 01/29/2010 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021299s022lbl.pdf | |
| 01/30/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021299s023lbl.pdf | |
| 03/06/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021299s021lbl.pdf | |
| 10/05/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s020lbl.pdf | |
| 08/03/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021299s019lbl.pdf | |
| 12/09/2006 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf | |
| 12/09/2006 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf | |
| 12/09/2006 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf | |
| 01/12/2005 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21299s013lbl.pdf | |
| 07/03/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf | |
| 07/03/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf |