Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020936
Company: APOTEX
Company: APOTEX
| 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 |
|---|---|---|---|---|---|
| 02/23/2024 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020936Orig1s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020936Orig1s065ltr.pdf | |
| 08/18/2023 | SUPPL-64 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020031Orig1s082;020710Orig1s050;020936Orig1s057,s064ltr.pdf | |
| 09/20/2021 | SUPPL-60 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020936s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/20031Orig1s012, 20710Orig1s047, 20936Orig1s060ltr.pdf | |
| 08/18/2023 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020031Orig1s082;020710Orig1s050;020936Orig1s057,s064ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 02/23/2024 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020936Orig1s065lbl.pdf | |
| 08/18/2023 | SUPPL-64 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf | |
| 08/18/2023 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf | |
| 08/18/2023 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf | |
| 09/20/2021 | SUPPL-60 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020936s060lbl.pdf | |
| 09/20/2021 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020936s060lbl.pdf | |
| 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 | 077873 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| 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 | 209748 | PRINSTON INC |
| 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 |
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 | 077873 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| 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 | 209748 | PRINSTON INC |
| 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 |
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 | 091427 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| 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 | 209293 | SCIECURE PHARMA INC |
| PAXIL CR | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020936 | APOTEX |