Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020710
Company: APOTEX
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 |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2021 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
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, 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 | |
| 04/10/2012 | SUPPL-32 | Labeling-Package Insert, Labeling |
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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf | |
| 09/20/2021 | SUPPL-47 | Labeling-Package Insert | 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf | |
| 04/10/2012 | SUPPL-32 | Labeling | 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 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s062s065s069,020710s026s029s033,020936s040s043lbl.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-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 |