Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203634
Company: SALIX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UCERIS BUDESONIDE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
01/14/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203634s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203634Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634_uceris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2020 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203634s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203634Orig1s007ltr.pdf
06/12/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/13/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203634s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203634Orig1s004ltr.pdf
07/06/2021 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

09/25/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/22/2014 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-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203634s007lbl.pdf
10/13/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203634s004lbl.pdf
01/14/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203634s000lbl.pdf

UCERIS

TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205457 ACTAVIS LABS FL INC
BUDESONIDE BUDESONIDE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208851 MYLAN
UCERIS BUDESONIDE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 203634 SALIX

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