Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020031
Company: APOTEX
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/29/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-82 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020031s082lbl.pdf | |
| 09/20/2021 | SUPPL-79 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/20031Orig1s012, 20710Orig1s047, 20936Orig1s060ltr.pdf | |
| 02/06/2021 | SUPPL-77 | 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-74 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020031Orig1s074,020710Orig1s038,020936Orig1s053ltr.pdf | |
| 07/18/2014 | SUPPL-71 | 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-69 | Labeling-Package Insert, 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-68 | 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-67 | Labeling, Labeling-Package Insert |
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-66 | Labeling-Package Insert |
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-65 | 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-63 | 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-62 | 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-61 | 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-60 | 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-59 | 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-58 | 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-55 | 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-54 | 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-53 | 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-52 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020031Orig1s052.pdf |
| 02/06/2006 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf |
| 08/22/2006 | SUPPL-49 | 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-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020031s048s051s052ltr.pdf |
| 03/09/2006 | SUPPL-46 | 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-45 | 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-43 | 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-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020031s042,020936s018ltr.pdf |
| 04/08/2004 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf |
| 04/08/2004 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20031slr039,040ltr.pdf |
| 10/02/2002 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20031se8-035ltr.pdf |
| 04/30/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/2001 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2001 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020031_S031_PAXIL_AP.pdf |
| 09/28/2000 | SUPPL-30 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S030_PAXIL_AP.pdf |
| 12/14/2001 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031s29ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S029.pdf | |
| 09/21/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S028_PAXIL_AP.pdf |
| 09/20/2000 | SUPPL-27 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S027_PAXIL_AP.pdf |
| 04/13/2001 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031S26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20031S26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-031S026_Paxil.cfm | |
| 05/17/2000 | SUPPL-25 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S025_PAXIL_AP.pdf |
| 05/11/1999 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20031s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20031s23ltr.pdf | |
| 02/19/1998 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/1998 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1997 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/1997 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/13/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/24/1997 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/11/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047,020936s060lbl.pdf | |
| 07/02/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/23/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/22/1994 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/29/1994 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-82 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020031s082lbl.pdf | |
| 08/18/2023 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020031s082lbl.pdf | |
| 09/20/2021 | SUPPL-79 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s012,020710s047lbl.pdf | |
| 09/20/2021 | SUPPL-79 | Labeling-Package Insert | 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 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020031s068,20710s032lbl.pdf | |
| 04/10/2012 | SUPPL-68 | Labeling-Package Insert | 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 |
PAXIL
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |