Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020031
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
PAXIL PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
PAXIL PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB Yes No
PAXIL PAROXETINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Discontinued None No No
PAXIL PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047lbl.pdf
09/20/2021 SUPPL-79 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047lbl.pdf
02/06/2021 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031Orig1s077,020710Orig1s045lbl.pdf
01/04/2017 SUPPL-74 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf
01/04/2017 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf
07/18/2014 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf
12/18/2012 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf
12/18/2012 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf
04/10/2012 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf
04/10/2012 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf
07/08/2011 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
07/08/2011 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
03/21/2011 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
10/27/2010 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf
08/07/2009 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf
01/30/2009 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf
10/31/2008 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf
08/02/2007 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf
01/12/2005 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20031s045,20936s020lbl.pdf
12/14/2001 SUPPL-29 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s29lbl.pdf
04/13/2001 SUPPL-26 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf
05/11/1999 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s23lbl.pdf
07/11/1996 SUPPL-12 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047,020936s060lbl.pdf

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