Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021365
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;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
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
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
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

LEXAPRO

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202227 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 203967 ANTRIM PHARMS LLC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 079062 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202221 HETERO LABS LTD III
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 090477 LANNETT CO INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202754 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 079121 TARO
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription Yes AA 021365 ALLERGAN SALES LLC

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