Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208025
Company: DEXCEL PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Over-the-counter None No 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
06/07/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208025Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208025Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208025Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208025Orig1s008ltr.pdf
11/30/2017 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s007ltr.pdf
11/30/2017 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025s006ltr.pdf
11/15/2017 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s005ltr.pdf
05/09/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s003ltr.pdf
01/25/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208025Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/09/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208025Orig1s008lbl.pdf
11/30/2017 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s007lbl.pdf
11/30/2017 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025s006lbl.pdf
05/09/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s003lbl.pdf
01/25/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208025Orig1s001lbl.pdf

LANSOPRAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 15MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Over-the-counter No 208025 DEXCEL PHARMA

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