Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022287
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXILANT DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
DEXILANT DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE;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
01/30/2009 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022287s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-26 Labeling-Medication Guide

Label is not available on this site.

10/24/2016 SUPPL-25 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s025,208056Orig1s003ltr.pdf
07/08/2016 SUPPL-23 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf
07/08/2016 SUPPL-22 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf
07/08/2016 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,022287Orig1s022,022287Orig1s023,208056Orig1s001ltr.pdf
02/02/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s020ltr.pdf
12/19/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022287Orig1s019ltr.pdf
12/16/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022287Orig1s018ltr.pdf
08/20/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022287Orig1s017ltr.pdf
12/20/2012 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/03/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s015ltr.pdf
09/28/2012 SUPPL-14 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s014ltr.pdf
05/20/2011 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s012ltr.pdf
10/28/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s011ltr.pdf
06/17/2011 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287Orig1s008ltr_replace.pdf
04/07/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s007ltr.pdf
09/03/2010 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s005ltr.pdf
03/19/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s004ltr.pdf
03/19/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s003ltr.pdf
06/22/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2016 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf
07/08/2016 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf
07/08/2016 SUPPL-22 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf
07/08/2016 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf
02/02/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf
12/16/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf
12/19/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf
08/20/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf
09/28/2012 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf
05/03/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf
10/28/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf
06/17/2011 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf
05/20/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf
04/07/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf
09/03/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf
09/03/2010 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf
06/22/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf
03/19/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf
03/19/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf

DEXILANT

CAPSULE, DELAYED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXILANT DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022287 TAKEDA PHARMS USA
DEXLANSOPRAZOLE DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 202294 PAR PHARM INC

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