Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022275
Company: OTSUKA AMERICA PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAMSCA TOLVAPTAN 15MG TABLET;ORAL Prescription None Yes No
SAMSCA TOLVAPTAN 30MG TABLET;ORAL Prescription None Yes Yes
SAMSCA TOLVAPTAN 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
05/19/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022275s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/23/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022275Orig1s016ltr.pdf
06/01/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022275s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022275Orig1s015ltr.pdf
02/28/2014 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022275Orig1s014ltr.pdf
05/02/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s011ltr.pdf
09/27/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/09/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s009ltr.pdf
09/14/2012 SUPPL-8 REMS-Assessment, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s008ltr.pdf
11/16/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s007ltr.pdf
02/01/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275s005ltr.pdf
09/23/2011 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022275s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/23/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbledt.pdf
06/01/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022275s015lbl.pdf
02/28/2014 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf
02/28/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf
05/02/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf
04/09/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf
11/16/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf
02/01/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf
05/19/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf

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