Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019839
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/1991 | 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-108 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019839Orig1s108,020990Orig1s062ltr.pdf | |
| 01/25/2023 | SUPPL-102 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s102,020990s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019839Orig1s102;020990Orig1s059ltr.pdf | |
| 09/20/2021 | SUPPL-100 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019839Orig1s100, 020990Orig1s057ltr.pdf | |
| 12/08/2017 | SUPPL-93 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf | |
| 12/08/2017 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s091s093,020990Orig1s049s050ltr.pdf | |
| 06/15/2017 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s088,020990s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019839Orig1s088,020990Orig1s046ltr.pdf | |
| 12/23/2016 | SUPPL-87 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf | |
| 12/23/2016 | SUPPL-86 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf | |
| 01/10/2014 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/19839Orig1s084,020990Orig1s043ltr.pdf | |
| 07/03/2014 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf | |
| 09/26/2013 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2012 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf | |
| 07/03/2014 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019839Orig1s080,s083,020990Orig1s039,s041ltr.pdf | |
| 02/01/2013 | SUPPL-79 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019839Orig1s079,20990Orig1s038ltr.pdf | |
| 08/19/2011 | SUPPL-76 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf | |
| 08/19/2011 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf | |
| 12/23/2016 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019839Orig1s074s086s087,020990Orig1s35s044s045ltr.pdf | |
| 12/18/2012 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019839Orig1s073,s081,020990Orig1s034,s040ltr.pdf | |
| 08/19/2011 | SUPPL-72 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019839s072,s075,s076,020990s033,s036,s037ltr.pdf | |
| 01/30/2009 | SUPPL-70 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019839s070,020990s032ltr.pdf | |
| 03/06/2008 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019839s068, 20990s031ltr.pdf | |
| 10/04/2007 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019839s065, 020990s029ltr.pdf | |
| 08/02/2007 | SUPPL-64 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf | |
| 08/02/2007 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf | |
| 09/14/2006 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf | |
| 08/02/2007 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf |
| 09/14/2006 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s058, 019839s060, 020990s024, 020990s026ltr.pdf | |
| 05/04/2006 | SUPPL-57 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019839s057, 020990s023ltr.pdf |
| 07/26/2005 | SUPPL-55 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019839s055,020990s022ltr.pdf |
| 02/18/2005 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf | |
| 02/18/2005 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19839s053,054,20990s019,020ltr.pdf | |
| 08/19/2004 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf | |
| 08/19/2004 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19839s047,050,20990s013,017ltr.pdf | |
| 02/07/2003 | SUPPL-45 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se1-045,20990se1-011ltr.pdf | |
| 09/16/2003 | SUPPL-44 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19839se5-se5-044,20990se5-010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019839s044,020990s010_ZoloftTOC.cfm | |
| 09/18/2002 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf |
| 01/09/2002 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/2001 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/2002 | SUPPL-39 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-839s039ltr.pdf | |
| 11/16/2000 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-36 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20990Se802,04,19839SE8-034,036LTR.pdf |
| 08/06/2001 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s35ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S35_Zoloft.cfm | |
| 09/20/2002 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19839s33ltr.pdf | |
| 03/17/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2000 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/07/1999 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft.cfm | |
| 04/10/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-18 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf |
| 10/10/1997 | SUPPL-17 | Efficacy-New Patient Population |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839ap.pdf |
| 03/05/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-11 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019839_s011ap.pdf |
| 03/06/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/22/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/14/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/25/1996 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/22/1992 | SUPPL-1 | Manufacturing (CMC) |
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-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf | |
| 01/25/2023 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s102,020990s059lbl.pdf | |
| 09/20/2021 | SUPPL-100 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf | |
| 09/20/2021 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf | |
| 12/08/2017 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf | |
| 12/08/2017 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf | |
| 06/15/2017 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s088,020990s046lbl.pdf | |
| 12/23/2016 | SUPPL-87 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 12/23/2016 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 12/23/2016 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 09/12/2014 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf | |
| 07/03/2014 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf | |
| 07/03/2014 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf | |
| 02/01/2013 | SUPPL-79 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf | |
| 12/18/2012 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf | |
| 12/18/2012 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf | |
| 08/19/2011 | SUPPL-76 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 08/19/2011 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 08/19/2011 | SUPPL-72 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 01/30/2009 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf | |
| 03/06/2008 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf | |
| 10/04/2007 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf | |
| 08/02/2007 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf | |
| 08/02/2007 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf | |
| 09/14/2006 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf | |
| 09/14/2006 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf | |
| 02/18/2005 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf | |
| 02/18/2005 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf | |
| 08/19/2004 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf | |
| 08/19/2004 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf | |
| 09/16/2003 | SUPPL-44 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf | |
| 02/07/2003 | SUPPL-45 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf | |
| 05/16/2002 | SUPPL-39 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf | |
| 10/12/2001 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf | |
| 08/06/2001 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-839S035_Zoloft_Prntlbl.pdf | |
| 12/07/1999 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf |
ZOLOFT
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | STRIDES PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | STRIDES PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | STRIDES PHARMA |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |