Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208056
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXILANT SOLUTAB DEXLANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Discontinued 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
01/26/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208056Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208056Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-3 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/2016/022287Orig1s026,208056Orig1s003ltr.pdf
07/08/2016 SUPPL-1 Efficacy-New Patient Population 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2016 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf
07/08/2016 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf
01/26/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208056lbl.pdf

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