Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022511
Company: HORIZON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIMOVO ESOMEPRAZOLE MAGNESIUM; NAPROXEN EQ 20MG BASE;500MG TABLET, DELAYED RELEASE;ORAL Prescription None Yes Yes
VIMOVO ESOMEPRAZOLE MAGNESIUM; NAPROXEN EQ 20MG BASE;375MG TABLET, 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
04/30/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022511s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022511Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022511s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022511Orig1s024ltr.pdf
06/07/2018 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022511Orig1s023ltr.pdf
10/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s020ltr.pdf
07/06/2017 SUPPL-19 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022511s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022511Orig1s019ltr.pdf
05/09/2016 SUPPL-18 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022511Orig1s018ltr.pdf
12/19/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s017ltr.pdf
06/19/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s016ltr.pdf
03/25/2015 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022511Orig1s015ltr.pdf
08/27/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/14/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/25/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s012ltr.pdf
03/20/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/27/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022511Orig1s010ltr.pdf
06/12/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/09/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s008ltr.pdf
09/28/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511Orig1s007ltr.pdf
01/20/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022511s006ltr.pdf
05/20/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s004ltr.pdf
06/21/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf
06/21/2011 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s002,s003ltr.pdf
11/18/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022511s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022511s024lbl.pdf
06/07/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf
06/07/2018 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf
07/06/2017 SUPPL-19 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022511s019lbl.pdf
10/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s020lbl.pdf
05/09/2016 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022511s018lbl.pdf
06/19/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s016lbl.pdf
03/25/2015 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022511s015lbl.pdf
12/19/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s017lbl.pdf
03/27/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s010lbl.pdf
02/25/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022511s012lbl.pdf
10/09/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s008lbl.pdf
09/28/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s007lbl.pdf
01/20/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022511s006lbl.pdf
11/18/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s001lbl.pdf
06/21/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf
06/21/2011 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s002s003lbl.pdf
05/20/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022511s004lbl.pdf
04/30/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022511lbl.pdf

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