Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205739
Company: RELYPSA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VELTASSA PATIROMER SORBITEX CALCIUM EQ 8.4GM BASE/PACKET POWDER;ORAL Prescription None Yes No
VELTASSA PATIROMER SORBITEX CALCIUM EQ 16.8GM BASE/PACKET POWDER;ORAL Prescription None Yes No
VELTASSA PATIROMER SORBITEX CALCIUM EQ 25.2GM BASE/PACKET POWDER;ORAL Prescription None 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
10/21/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205739Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205739Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2018 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205739Orig1s016ltr.pdf
12/01/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/25/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s009ltr.pdf
06/16/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/10/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/2016 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205739Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/02/2018 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205739s016lbl.pdf
11/25/2016 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf
11/25/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s009lbl.pdf
05/20/2016 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf
05/20/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205739s001lbl.pdf
10/21/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205739s000lbl.pdf

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