Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021299
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 Prescription None Yes No
PEXEVA PAROXETINE MESYLATE EQ 20MG BASE TABLET;ORAL Prescription None Yes No
PEXEVA PAROXETINE MESYLATE EQ 30MG BASE TABLET;ORAL Prescription None Yes No
PEXEVA PAROXETINE MESYLATE EQ 40MG BASE TABLET;ORAL Prescription None 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
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
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
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-Medication Guide, 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
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
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/nda/2001/21-299.pdf_Paroxetine%20Mesylate_Prntlbl.pdf
07/03/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf

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