Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021365
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEXAPRO | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/27/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21365_Lexapro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21365ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-365_Lexapro.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/2024 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021365s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020822Orig1s055; 021365Orig1s041; 021323Orig1s058; 022567Orig1s025; 204168Orig1s012ltr.pdf | |
| 08/18/2023 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s057,021365s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021323Orig1s057,021365Orig1s040ltr.pdf | |
| 05/12/2023 | SUPPL-39 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s055,021365s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021323Orig1s055,021365Orig1s039ltr.pdf | |
| 09/20/2021 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020822Orig1s052, 021365Orig1s038, 021323Orig1s053, 022567Orig1s022, 204168Orig1s007ltr.pdf | |
| 08/28/2020 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021323s052,021365s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021323Orig1s052, 021365Orig1s037ltr.pdf | |
| 01/11/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021323s051,021365s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020822Oirg1s051,021323Orig1s051,021365Orig1s036ltr.pdf | |
| 01/04/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021365s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf | |
| 07/08/2014 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf | |
| 10/31/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021323Orig1s044,021365Orig1s032ltr.pdf | |
| 12/03/2012 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021365s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf | |
| 03/11/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s035,021365s025ltr.pdf | |
| 05/12/2011 | SUPPL-24 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021323s033,021365s024ltr.pdf | |
| 01/30/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf | |
| 03/19/2009 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf | |
| 03/19/2009 | SUPPL-21 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021323s030,s031,021365s021,s022ltr.pdf | |
| 10/11/2008 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s029, 021365s019ltr.pdf |
| 09/18/2008 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021323s028,s029,021365s018,s019ltr.pdf | |
| 08/02/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/18/2005 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf |
| 05/20/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf |
| 01/11/2005 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21323s014,21365s007ltr.pdf |
| 04/08/2004 | SUPPL-5 |
Label is not available on this site. |
|||
| 12/18/2003 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf | |
| 12/18/2003 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21323se1-003,se8-007,21365se8-001,se1-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/19/2024 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021365s041lbl.pdf | |
| 08/18/2023 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s057,021365s040lbl.pdf | |
| 08/18/2023 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s057,021365s040lbl.pdf | |
| 05/12/2023 | SUPPL-39 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s055,021365s039lbl.pdf | |
| 09/20/2021 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf | |
| 09/20/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf | |
| 08/28/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021323s052,021365s037lbl.pdf | |
| 01/11/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021323s051,021365s036lbl.pdf | |
| 01/04/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021365s035lbl.pdf | |
| 10/31/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf | |
| 07/08/2014 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf | |
| 12/03/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021365s030lbl.pdf | |
| 05/12/2011 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf | |
| 03/11/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf | |
| 03/19/2009 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf | |
| 03/19/2009 | SUPPL-21 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf | |
| 01/30/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf | |
| 09/18/2008 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf | |
| 12/18/2003 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf | |
| 12/18/2003 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf | |
| 11/27/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21365_Lexapro_lbl.pdf |