Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020936
Company: APOTEX TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;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
02/16/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20936lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20936ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-936_Paxil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-53 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf
07/18/2014 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020936s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf
09/11/2019 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020936s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020936Orig1s047ltr.pdf
04/10/2012 SUPPL-46 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf
12/18/2012 SUPPL-45 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf
07/08/2011 SUPPL-44 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf
03/21/2011 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf
10/27/2010 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020936s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf
03/21/2011 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s062s065s069,020710s026s029s033,020936s040s043ltr.pdf
07/17/2009 SUPPL-39 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020936s039ltr.pdf
01/30/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf
10/31/2008 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020031s060, 020936s037, 020710s024ltr.pdf
08/07/2009 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf
07/08/2011 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf
08/22/2006 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf
08/22/2006 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf
08/02/2007 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020936s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf
02/06/2006 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf
02/06/2006 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf
08/22/2006 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020301s49s54s55,20936s23s30s31,20710s18s19ltr.pdf
02/06/2006 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s022s026s027_ltr.pdf
03/09/2006 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020936s021,020031s046ltr.pdf
01/12/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20031s045,20936s020ltr.pdf
05/21/2004 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr043,20936slr019ltr.pdf
07/13/2005 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf
01/27/2004 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20936se2-013_paxil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20936se2-013ltr.pdf
10/16/2003 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-012_paxil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S012_PAXIL_AP.pdf
08/28/2003 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-011_paxil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20936se1-011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020936_S011_PAXIL CR.pdf
07/22/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20982lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20982ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-936s008_Paroxetine_PaxilCR.cfm
04/30/2001 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s007.pdf
04/30/2001 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020936Orig1s006.pdf
12/06/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/18/2000 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s004.pdf
09/21/2000 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s003.pdf
08/17/2000 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020936Orig1s002.pdf
07/02/1999 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020936Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/11/2019 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020936s047lbl.pdf
01/04/2017 SUPPL-53 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf
01/04/2017 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf
07/18/2014 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020936s049lbl.pdf
12/18/2012 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s045lbl.pdf
12/18/2012 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s045lbl.pdf
04/10/2012 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s046lbl.pdf
04/10/2012 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020936s046lbl.pdf
07/08/2011 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf
07/08/2011 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf
07/08/2011 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020936s034s044lbl.pdf
03/21/2011 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
10/27/2010 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020936s041lbl.pdf
08/07/2009 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s035lbl.pdf
01/30/2009 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020936s038lbl.pdf
10/31/2008 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf
08/02/2007 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020936s029lbl.pdf
01/12/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf
01/27/2004 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20936se2-013_paxil_lbl.pdf
10/16/2003 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-012_paxil_lbl.pdf
08/28/2003 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20936se1-011_paxil_lbl.pdf
02/12/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20982lbl.pdf
02/16/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20936lbl.pdf

PAXIL CR

TABLET, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

TABLET, EXTENDED RELEASE;ORAL; EQ 37.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091427 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

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