Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022101
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription 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
02/27/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022101s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101_nexium_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-16 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-15 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-14 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-13 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
03/27/2014 SUPPL-12 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
11/28/2012 SUPPL-11 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-10 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-9 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-8 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-7 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-6 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-5 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-4 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-3 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-1 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s051,021957s018,022101s015lbl.pdf
10/24/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf
12/19/2014 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf
12/19/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf
03/27/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf
02/25/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf
11/28/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf
10/09/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf
09/28/2012 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf
01/20/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf
06/30/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf
06/21/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf
09/03/2010 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf
03/04/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf
10/09/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf
01/15/2009 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf
02/27/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022101lbl.pdf

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