Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205613
Company: SALIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UCERIS BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM;RECTAL 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
10/07/2014 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2020 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205613Orig1s004ltr.pdf
11/13/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/09/2020 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf
04/09/2020 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205613s004lbl.pdf
10/07/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf

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