Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020990
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 12/07/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20990ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20990_Zoloft.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-62 | 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-59 | 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-57 | Labeling-Package Insert, Labeling-Medication Guide |
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-50 | 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-49 | 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-46 | Labeling |
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-45 | 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 | |
| 12/23/2016 | SUPPL-44 | 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 | |
| 09/12/2014 | SUPPL-43 | 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 | |
| 10/15/2013 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2014 | SUPPL-41 | 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 | |
| 12/18/2012 | SUPPL-40 | 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-39 | 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-38 | 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-37 | 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-36 | 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-35 | 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-34 | 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-33 | 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-32 | 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-31 | 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-29 | 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-27 | 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-26 | 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-25 | 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-24 | 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-23 | 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-22 | 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-20 | 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-19 | 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-17 | 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-13 | 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-11 | 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-10 | 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-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19839slr043,20990slr009ltr.pdf |
| 05/16/2002 | SUPPL-7 | 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-6 | Labeling |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-4 | 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-3 | 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-2 | 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 |
| 10/12/2001 | SUPPL-1 | 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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf | |
| 01/25/2023 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s102,020990s059lbl.pdf | |
| 09/20/2021 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf | |
| 09/20/2021 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf | |
| 12/08/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf | |
| 12/08/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf | |
| 06/15/2017 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s088,020990s046lbl.pdf | |
| 12/23/2016 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 12/23/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 12/23/2016 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s074,019839s086,019839s087,020990s035s044s045lbl.pdf | |
| 09/12/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf | |
| 07/03/2014 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf | |
| 07/03/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf | |
| 02/01/2013 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019839s079,020990s038lbl.pdf | |
| 12/18/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf | |
| 12/18/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/19839s073,s081,20990s034s040lbl.pdf | |
| 08/19/2011 | SUPPL-37 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 08/19/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 08/19/2011 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf | |
| 01/30/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf | |
| 03/06/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf | |
| 10/04/2007 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s065,020990s029lbl.pdf | |
| 08/02/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019839s063s064,020990s027lbl.pdf | |
| 09/14/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf | |
| 09/14/2006 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf | |
| 02/18/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf | |
| 02/18/2005 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf | |
| 08/19/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf | |
| 08/19/2004 | SUPPL-13 | 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-10 | 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-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf | |
| 05/16/2002 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19839s39lbl.pdf | |
| 10/12/2001 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20990s1lbl.pdf | |
| 08/06/2001 | SUPPL-3 | 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 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20990lbl.pdf |
ZOLOFT
CONCENTRATE;ORAL; EQ 20MG BASE/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | CONCENTRATE;ORAL | Prescription | No | AA | 076934 | ACI |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | CONCENTRATE;ORAL | Prescription | No | AA | 078861 | AUROBINDO PHARMA |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | CONCENTRATE;ORAL | Prescription | Yes | AA | 020990 | VIATRIS |