Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021323
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
LEXAPRO ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
LEXAPRO ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;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
08/14/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21323lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-323_Lexapro.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf
01/28/2016 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/08/2014 SUPPL-45 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-44 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
05/29/2013 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/03/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021323s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf
03/07/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/11/2011 SUPPL-35 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-33 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-32 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-31 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf
03/19/2009 SUPPL-30 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf
10/11/2008 SUPPL-29 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-28 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-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021323s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf
02/18/2005 SUPPL-20 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-15 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-14 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-10

Label is not available on this site.

12/18/2003 SUPPL-7 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
12/18/2003 SUPPL-3 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
12/13/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/29/2002 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323se8-001and21440ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf
10/31/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323s044,021365s032lbl.pdf
07/08/2014 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021323Orig1s045,021365Orig1s033lbl.pdf
12/03/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021323s040lbl.pdf
05/12/2011 SUPPL-33 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf
03/11/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf
03/19/2009 SUPPL-31 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf
03/19/2009 SUPPL-30 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s030s031,021365s021s022lbl.pdf
01/30/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021323s032,021365s023lbl.pdf
09/18/2008 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021323s28s29,021365s18s19lbl.pdf
08/02/2007 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021323s025lbl.pdf
12/18/2003 SUPPL-7 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
12/18/2003 SUPPL-3 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
08/29/2002 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf
08/14/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21323lbl.pdf

LEXAPRO

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078777 APOTEX INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078766 HIKMA PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202210 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077550 MYLAN PHARMS INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077512 STI PHARMA LLC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077734 ZYDUS PHARMS USA INC
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 021323 FOREST LABS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078777 APOTEX INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078766 HIKMA PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202210 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077550 MYLAN PHARMS INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077512 STI PHARMA LLC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077734 ZYDUS PHARMS USA INC
LEXAPRO ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021323 FOREST LABS

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078777 APOTEX INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078766 HIKMA PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 202210 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 077550 MYLAN PHARMS INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 077512 STI PHARMA LLC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 077734 ZYDUS PHARMS USA INC
LEXAPRO ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021323 FOREST LABS

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