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New Drug Application (NDA): 020710
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;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
06/25/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2021 SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/20031Orig1s012, 20710Orig1s047, 20936Orig1s060ltr.pdf
02/06/2021 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031Orig1s077,020710Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020031Orig1s077; 020710Orig1s045ltr.pdf
01/04/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020710s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf
07/18/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020031Orig1s071,020710Orig1s035,020936Orig1s049ltr.pdf
03/21/2011 SUPPL-33 Labeling-Package Insert, 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
04/10/2012 SUPPL-32 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031s068,020710s032,020936s046ltr.pdf
12/18/2012 SUPPL-31 Labeling-Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020031Orig1s067,020710Orig1s031,020936Orig1s045ltr.pdf
07/08/2011 SUPPL-30 Labeling-Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf
03/21/2011 SUPPL-29 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-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020031s063,020710s027,020936s041ltr.pdf
03/21/2011 SUPPL-26 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
01/30/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s061,020936s038,020710s025ltr.pdf
10/31/2008 SUPPL-24 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-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020031s059,020710s023,020936s035ltr.pdf
07/08/2011 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020031s058,s066,020710s022,s030,020936s034,s044ltr.pdf
08/22/2006 SUPPL-19 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-18 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-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/012342s059, 020031s053, 020710s017, 020936s029ltr.pdf
02/06/2006 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf
02/06/2006 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020710s015s016_ltr.pdf
11/08/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2001 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s011.pdf
04/30/2001 SUPPL-10 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020710Orig1s010.pdf
02/15/2001 SUPPL-9 Labeling

Label is not available on this site.

09/28/2000 SUPPL-8 Labeling

Label is not available on this site.

07/18/2000 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020710Orig1s007.pdf
09/21/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/1999 SUPPL-4 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020710_S004_PAXIL_TABLETS.pdf
02/20/1998 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020710_S002_PAXIL_TABLETS.pdf
11/06/1997 SUPPL-1 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020710_S001_PAXIL_TABLETS.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf
09/20/2021 SUPPL-47 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf
02/06/2021 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031Orig1s077,020710Orig1s045lbl.pdf
01/04/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020710s038lbl.pdf
07/18/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020031s071,020710s035lbl.pdf
12/18/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf
12/18/2012 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s067,020710s031.pdf
04/10/2012 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf
04/10/2012 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf
07/08/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
07/08/2011 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
07/08/2011 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
03/21/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
03/21/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.pdf
10/27/2010 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020031s063,020710s027lbl.pdf
08/07/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s05920710s023lbl.pdf
01/30/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020031s061,020710s025lbl.pdf
10/31/2008 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020031s060,020936s037,020710s024lbl.pdf
08/02/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020031s053,020710s017lbl.pdf

PAXIL

SUSPENSION;ORAL; EQ 10MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;ORAL Prescription No AB 215003 NOVITIUM PHARMA
PAXIL PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML SUSPENSION;ORAL Prescription Yes AB 020710 APOTEX
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