Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021153
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;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
02/20/2001 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2018 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021153Orig1s053,022101Orig1s017,021957Orig1s020ltr.pdf
10/24/2016 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf
12/20/2016 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021957Orig1s018,021153Orig1s051,022101Orig1s015ltr.pdf
12/19/2014 SUPPL-50 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf
02/25/2014 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf
02/14/2014 SUPPL-48 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021153Orig1s048.pdf
10/04/2013 SUPPL-47 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s047.pdf
03/27/2014 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf
06/17/2013 SUPPL-45 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s045.pdf
11/28/2012 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf
09/28/2012 SUPPL-43 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf
10/09/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf
01/20/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf
06/30/2011 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf
09/03/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf
06/21/2011 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf
03/04/2010 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf
10/09/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf
01/15/2009 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf
01/11/2008 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf
04/27/2007 SUPPL-28 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
04/27/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf
09/26/2006 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s025ltr.pdf
09/15/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s024ltr.pdf
10/11/2006 SUPPL-23 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s023LTR.pdf
04/28/2006 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s022LTR.pdf
02/16/2006 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s021ltr.pdf
06/06/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021153s020ltr.pdf
11/24/2004 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153s019ltr.pdf
04/23/2004 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153_S015_NEXIUM_DELAYED_RELEASE.pdf
01/09/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153Orig1s008.pdf
10/01/2002 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/20/2002 SUPPL-5 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21153slr005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-153S005_review.pdf
02/27/2003 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21153slr004ltr.pdf
03/14/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/16/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/16/2001 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
06/07/2018 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf
12/20/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf
10/24/2016 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf
12/19/2014 SUPPL-50 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf
12/19/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf
03/27/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf
02/25/2014 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf
11/28/2012 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf
10/09/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf
09/28/2012 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf
01/20/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf
06/30/2011 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf
06/21/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf
09/03/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf
03/04/2010 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf
10/09/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf
01/15/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf
04/27/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
04/27/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
10/11/2006 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf
09/26/2006 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf
09/15/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf
04/28/2006 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf
02/16/2006 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf
06/06/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf
11/24/2004 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf
04/23/2004 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf
01/09/2004 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf
02/20/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf

NEXIUM

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 208333 ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205606 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078279 DR REDDYS LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209495 GLENMARK PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202784 HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078003 IVAX SUB TEVA PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205563 LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078936 MYLAN
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209735 SUN PHARM
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203636 TORRENT
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 206296 ZYDUS PHARMS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021153 ASTRAZENECA PHARMS

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 208333 ALKEM LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205606 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078279 DR REDDYS LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209495 GLENMARK PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202784 HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078003 IVAX SUB TEVA PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205563 LANNETT CO INC
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078936 MYLAN
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 209735 SUN PHARM
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203636 TORRENT
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 206296 ZYDUS PHARMS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription Yes AB 021153 ASTRAZENECA PHARMS

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